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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02308111
Registration number
NCT02308111
Ethics application status
Date submitted
10/11/2014
Date registered
4/12/2014
Date last updated
9/03/2023
Titles & IDs
Public title
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
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Scientific title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis
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Secondary ID [1]
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747-302
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Universal Trial Number (UTN)
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Trial acronym
COBALT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Cirrhosis, Biliary
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Infection
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Other infectious diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Obeticholic Acid (OCA)
Treatment: Drugs - Placebo
Experimental: Obeticholic Acid (OCA) 5 mg to 10 mg - Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).
Placebo comparator: Placebo -
Treatment: Drugs: Obeticholic Acid (OCA)
Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants).
Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study.
Treatment: Drugs: Placebo
One tablet daily (or a lower frequency depending on CP score) for the remainder of the study
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the First Occurrence of Composite Endpoint
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Assessment method [1]
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To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) =15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of \>=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.
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Timepoint [1]
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Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
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Primary outcome [2]
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Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)
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Assessment method [2]
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Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score \>=15 (MELD-Na score \>=12 baseline), MELD-Na score \>=15 (MELD-Na score \<12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
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Timepoint [2]
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Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
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Secondary outcome [1]
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Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint
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Assessment method [1]
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The first occurrence of the key secondary clinical event refers to the first occurrence of the following events: death, liver transplant, MELD-Na score \>=15 if MELD-Na\< 12 at baseline, MELD score \>=15 if MELD-Na \>=12 at baseline, uncontrolled or refractory ascites, portal hypertension syndromes (hepatorenal syndrome, portopulmonary syndrome, hepatopulmonary syndrome) or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or bacterial empyema. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
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Timepoint [1]
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Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years)
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Secondary outcome [2]
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Time To Liver Transplant Or Death (All-cause)
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Assessment method [2]
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The effect of OCA compared to placebo on time to liver transplant or death (all-cause) was assessed. The events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.
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Timepoint [2]
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Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years)
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Secondary outcome [3]
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Time to First Occurrence of Fatal Event (All-Cause)
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Assessment method [3]
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The results represent the ratio of OCA to placebo. The fatal events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the fatal events distribution percentiles (25th and 50th) are provided
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Timepoint [3]
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Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years)
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Secondary outcome [4]
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Time to First Occurrence of Liver Transplant
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Assessment method [4]
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The effect of OCA compared to placebo on time to occurrence of a liver transplant was assessed. The results represented the ratio of OCA to placebo. A hazard ratio \<1 indicated an advantage for OCA. The event of interest was summarized through Cumulative Incidence Function (CIF) estimate at 5 years.
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Timepoint [4]
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Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years)
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Secondary outcome [5]
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Time to First Occurrence of Hospitalization Due to Hepatic Events
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Assessment method [5]
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Hospitalization events include new onset or recurrent variceal bleed, hepatic encephalopathy (as defined by a West Haven score of \>=2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis OR presence of \>250/mm\^3 polymorph leucocytes \[PMNs\] in the ascitic fluid), bacterial empyema is confirmed by diagnostic thoracentesis OR presence of \>250/mm\^3 PMNs in the pleural fluid. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [5]
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Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years)
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Secondary outcome [6]
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Time to First Occurrence of Uncontrolled or Refractory Ascites
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Assessment method [6]
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Uncontrolled or refractory ascites are defined as diuretic-resistant ascites requiring large-volume paracentesis. The effect of OCA compared to placebo on time to the first occurrence of uncontrolled or refractory ascites was assessed. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [6]
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Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years)
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Secondary outcome [7]
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Time to First Occurrence of MELD Score =15
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Assessment method [7]
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The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and International Normalized Ratio (INR), as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [7]
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Time to first occurrence from date of randomization until the date of first documented MELD Score =15, liver transplant or date of death from any cause, whichever came first (up to 5 years)
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Secondary outcome [8]
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Time To Development Of Varix/Varices
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Assessment method [8]
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The effect of OCA compared to placebo on time to development of varix/varices was assessed. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [8]
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Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years)
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Secondary outcome [9]
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Time To Liver-Related Death
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Assessment method [9]
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The effect of OCA compared to placebo on time to liver-related death was assessed. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [9]
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Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years)
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Secondary outcome [10]
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Time To Liver-Related Death Or Liver Transplant
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Assessment method [10]
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The effect of OCA compared to placebo on time to liver-related death or liver transplant was assessed. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [10]
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Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years)
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Secondary outcome [11]
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Time To Liver-Related Death, Liver Transplant, Or MELD Score =15
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Assessment method [11]
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The effect of OCA compared to placebo on time to liver-related death, liver transplant, or MELD Score =15 was assessed. The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [11]
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Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score =15, whichever came first (up to 5 years)
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Secondary outcome [12]
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Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline)
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Assessment method [12]
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When a participant is identified as noncirrhotic at the Baseline and exhibited any signs or symptoms associated with progression to cirrhosis, the participant was assessed by Fibroscan® TE where available. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [12]
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Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years)
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Secondary outcome [13]
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Time To Occurrence Of Hepatocellular Carcinoma (HCC)
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Assessment method [13]
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The effect of OCA compared to placebo on time to occurrence of HCC was assessed. The event of interest was summarized through CIF estimate at 5 years.
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Timepoint [13]
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Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years)
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Secondary outcome [14]
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Change From Baseline To Month 24 Of Total Bilirubin
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Assessment method [14]
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Liver biochemistry, which includes total bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using mixed model repeated measures (MMRM), including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [14]
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Baseline up to Month 24
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Secondary outcome [15]
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Change From Baseline To Month 24 Of Direct Bilirubin
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Assessment method [15]
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Liver biochemistry, which includes direct bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [15]
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Baseline up to Month 24
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Secondary outcome [16]
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Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST)
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Assessment method [16]
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Liver biochemistry, which includes AST, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [16]
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Baseline up to Month 24
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Secondary outcome [17]
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Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT)
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Assessment method [17]
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Liver biochemistry, which includes ALT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [17]
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Baseline up to Month 24
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Secondary outcome [18]
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Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP)
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Assessment method [18]
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Liver biochemistry, which includes ALP, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [18]
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Baseline up to Month 24
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Secondary outcome [19]
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Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT)
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Assessment method [19]
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Liver biochemistry, which includes GGT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [19]
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Baseline up to Month 24
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Secondary outcome [20]
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Change From Baseline To Month 24 Of Albumin
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Assessment method [20]
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Liver biochemistry, which includes albumin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [20]
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Baseline up to Month 24
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Secondary outcome [21]
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Change From Baseline To Month 24 Of INR
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Assessment method [21]
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The coagulation test, which includes INR, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. INR is the ratio of tested prothrombin time to normal prothrombin time, to a power designated the international sensitivity index (ISI). INR normal range is 0.8 to 1.2 (female and male). Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.
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Timepoint [21]
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Baseline up to Month 24
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Secondary outcome [22]
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Change From Baseline To Month 72 Of MELD Score
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Assessment method [22]
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The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
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Timepoint [22]
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Baseline up to Month 72
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Secondary outcome [23]
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Change From Baseline To Month 72 Of MELD-Na Score
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Assessment method [23]
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The MELD-Na score is another useful predictor in assessing participants with significant decompensation. The MELD-Na took into account the effect of serum sodium as a reflection of renal function and hypothetically may improve the accuracy of the model score. The MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and serum sodium, as appropriate, to predict survival. The MELD-Na score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.
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Timepoint [23]
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Baseline up to Month 72
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Secondary outcome [24]
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Change From Baseline To Month 72 Of CPS
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Assessment method [24]
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Child-Pugh Score (Pugh 1973, Lucey 1997) was calculated and reported within the electronic data capture (EDC) system based on data entered into the CRF by adding the scores from the 5 factors and could have ranged from 5 to15. A total score of 5 to 6 was considered Grade A (mild, well-compensated disease); 7 to 9 was Grade B (moderate, significant functional compromise); and 10 and above was Grade C (severe, decompensated disease).
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Timepoint [24]
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Baseline up to Month 72
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Secondary outcome [25]
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Change From Baseline To Month 72 Of Mayo Risk Score (MRS)
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Assessment method [25]
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Mayo Risk Score (MRS) was calculated and reported within the EDC system. Calculation of MRS included Investigator assessment of peripheral edema and the use of diuretic therapy, which was assessed during the adverse event and concomitant medicine review at the scheduled visits and entered into the CRF, as well as total bilirubin, albumin, and prothrombin time results obtained from the central laboratory data. There is no maximum and minimum range of score but an increase in the MRS represents an increase in the risk of death.
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Timepoint [25]
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Baseline up to Month 72
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Secondary outcome [26]
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Change From Baseline To Month 72 Of Immunoglobulin-M (IgM)
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Assessment method [26]
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Markers of inflammation, which include IgM, were assessed.
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Timepoint [26]
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Baseline up to Month 72
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Secondary outcome [27]
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Change From Baseline To Month 72 Of C-reactive Protein (CRP)
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Assessment method [27]
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Markers of inflammation, which include CRP, were assessed.
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Timepoint [27]
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Baseline up to Month 72
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Secondary outcome [28]
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Change From Baseline To Month 72 Of Tumor Necrosis Factor-a (TNF-a)
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Assessment method [28]
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Markers of inflammation, which include TNF-a, were assessed.
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Timepoint [28]
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Baseline up to Month 72
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Secondary outcome [29]
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Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19)
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Assessment method [29]
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Markers of hepatic fibrosis, which include FGF-19, were assessed.
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Timepoint [29]
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Baseline up to Month 72
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Secondary outcome [30]
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Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18)
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Assessment method [30]
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Markers of inflammation, which include CK-18, were assessed.
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Timepoint [30]
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Baseline up to Month 72
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Secondary outcome [31]
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Change From Baseline To Month 72 Of 7a-hydroxy-4-cholesten-3-one (C4)
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Assessment method [31]
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Markers of hepatic fibrosis, which include C4, were assessed.
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Timepoint [31]
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Baseline up to Month 72
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Secondary outcome [32]
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Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF)
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Assessment method [32]
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Liver fibrosis was assessed using ELF test. The ELF test assessed: hyaluronic acid, procollagen3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1. The ELF test is a composite score: \< 7.7: no to mild fibrosis; = 7.7 - \< 9.8: Moderate fibrosis; = 9.8 - \< 11.3: Severe fibrosis; = 11.3: Cirrhosis. A negative change from Baseline suggests decreased fibrosis.
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Timepoint [32]
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Baseline up to Month 72
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Secondary outcome [33]
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Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography
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Assessment method [33]
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Hepatic stiffness was measured using non-invasive transient Elastography with Fibroscan® TE device.
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Timepoint [33]
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Baseline up to Month 72
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Secondary outcome [34]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [34]
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An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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Timepoint [34]
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Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years)
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Secondary outcome [35]
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Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen
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Assessment method [35]
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The fasting trough PK concentrations of OCA of different dose regimens taken throughout the study are reported.
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Timepoint [35]
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Months 3, 6, 9, 12, 24, 36, 48, and 60
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Secondary outcome [36]
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PK Population: Serial Concentration of OCA By Dose Regimen
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Assessment method [36]
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In Month 9, blood samples were collected at predose, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h and PK serial concentrations at different dose regimen are reported.
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Timepoint [36]
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Month 9
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Secondary outcome [37]
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PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC)
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Assessment method [37]
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In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [37]
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0
Month 9
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Secondary outcome [38]
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PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC
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Assessment method [38]
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0
In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [38]
0
0
Month 9
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Secondary outcome [39]
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PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
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Assessment method [39]
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In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [39]
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0
Month 9
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Secondary outcome [40]
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PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
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Assessment method [40]
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0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [40]
0
0
Month 9
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Secondary outcome [41]
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0
PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC
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Assessment method [41]
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0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [41]
0
0
Month 9
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Secondary outcome [42]
0
0
PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC
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Assessment method [42]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.
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Timepoint [42]
0
0
Month 9
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Secondary outcome [43]
0
0
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A
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Assessment method [43]
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In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
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Timepoint [43]
0
0
Month 9
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Secondary outcome [44]
0
0
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A
Query!
Assessment method [44]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [44]
0
0
Month 9
Query!
Secondary outcome [45]
0
0
PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Query!
Assessment method [45]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [45]
0
0
Month 9
Query!
Secondary outcome [46]
0
0
PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Query!
Assessment method [46]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [46]
0
0
Month 9
Query!
Secondary outcome [47]
0
0
PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A
Query!
Assessment method [47]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [47]
0
0
Month 9
Query!
Secondary outcome [48]
0
0
PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A
Query!
Assessment method [48]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [48]
0
0
Month 9
Query!
Secondary outcome [49]
0
0
PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A
Query!
Assessment method [49]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.
Query!
Timepoint [49]
0
0
Month 9
Query!
Secondary outcome [50]
0
0
PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B
Query!
Assessment method [50]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=B.
Query!
Timepoint [50]
0
0
Month 9
Query!
Secondary outcome [51]
0
0
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
Query!
Assessment method [51]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [51]
0
0
Month 9
Query!
Secondary outcome [52]
0
0
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC
Query!
Assessment method [52]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC
Query!
Timepoint [52]
0
0
Month 9
Query!
Secondary outcome [53]
0
0
PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Query!
Assessment method [53]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [53]
0
0
Month 9
Query!
Secondary outcome [54]
0
0
PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Query!
Assessment method [54]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [54]
0
0
Month 9
Query!
Secondary outcome [55]
0
0
PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Query!
Assessment method [55]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [55]
0
0
Month 9
Query!
Secondary outcome [56]
0
0
PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Query!
Assessment method [56]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [56]
0
0
Month 9
Query!
Secondary outcome [57]
0
0
PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC
Query!
Assessment method [57]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.
Query!
Timepoint [57]
0
0
Month 9
Query!
Secondary outcome [58]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [58]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [58]
0
0
Month 9
Query!
Secondary outcome [59]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [59]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [59]
0
0
Month 9
Query!
Secondary outcome [60]
0
0
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [60]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [60]
0
0
Month 9
Query!
Secondary outcome [61]
0
0
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [61]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [61]
0
0
Month 9
Query!
Secondary outcome [62]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [62]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [62]
0
0
Month 9
Query!
Secondary outcome [63]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [63]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [63]
0
0
Month 9
Query!
Secondary outcome [64]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC
Query!
Assessment method [64]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.
Query!
Timepoint [64]
0
0
Month 9
Query!
Secondary outcome [65]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A
Query!
Assessment method [65]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [65]
0
0
Month 9
Query!
Secondary outcome [66]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A
Query!
Assessment method [66]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [66]
0
0
Month 9
Query!
Secondary outcome [67]
0
0
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
Query!
Assessment method [67]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [67]
0
0
Month 9
Query!
Secondary outcome [68]
0
0
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A
Query!
Assessment method [68]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [68]
0
0
Month 9
Query!
Secondary outcome [69]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A
Query!
Assessment method [69]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [69]
0
0
Month 9
Query!
Secondary outcome [70]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A
Query!
Assessment method [70]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [70]
0
0
Month 9
Query!
Secondary outcome [71]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A
Query!
Assessment method [71]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.
Query!
Timepoint [71]
0
0
Month 9
Query!
Secondary outcome [72]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [72]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [72]
0
0
Month 9
Query!
Secondary outcome [73]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [73]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [73]
0
0
Month 9
Query!
Secondary outcome [74]
0
0
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [74]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [74]
0
0
Month 9
Query!
Secondary outcome [75]
0
0
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [75]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [75]
0
0
Month 9
Query!
Secondary outcome [76]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [76]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [76]
0
0
Month 9
Query!
Secondary outcome [77]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [77]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B
Query!
Timepoint [77]
0
0
Month 9
Query!
Secondary outcome [78]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B
Query!
Assessment method [78]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.
Query!
Timepoint [78]
0
0
Month 9
Query!
Secondary outcome [79]
0
0
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [79]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [79]
0
0
Month 9
Query!
Secondary outcome [80]
0
0
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [80]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [80]
0
0
Month 9
Query!
Secondary outcome [81]
0
0
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [81]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [81]
0
0
Month 9
Query!
Secondary outcome [82]
0
0
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [82]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [82]
0
0
Month 9
Query!
Secondary outcome [83]
0
0
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [83]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [83]
0
0
Month 9
Query!
Secondary outcome [84]
0
0
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [84]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [84]
0
0
Month 9
Query!
Secondary outcome [85]
0
0
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A
Query!
Assessment method [85]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.
Query!
Timepoint [85]
0
0
Month 9
Query!
Secondary outcome [86]
0
0
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [86]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [86]
0
0
Month 9
Query!
Secondary outcome [87]
0
0
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [87]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [87]
0
0
Month 9
Query!
Secondary outcome [88]
0
0
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [88]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [88]
0
0
Month 9
Query!
Secondary outcome [89]
0
0
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [89]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [89]
0
0
Month 9
Query!
Secondary outcome [90]
0
0
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [90]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [90]
0
0
Month 9
Query!
Secondary outcome [91]
0
0
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [91]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [91]
0
0
Month 9
Query!
Secondary outcome [92]
0
0
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B
Query!
Assessment method [92]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.
Query!
Timepoint [92]
0
0
Month 9
Query!
Secondary outcome [93]
0
0
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [93]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [93]
0
0
Month 9
Query!
Secondary outcome [94]
0
0
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [94]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [94]
0
0
Month 9
Query!
Secondary outcome [95]
0
0
PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [95]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [95]
0
0
Month 9
Query!
Secondary outcome [96]
0
0
PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [96]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [96]
0
0
Month 9
Query!
Secondary outcome [97]
0
0
PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [97]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [97]
0
0
Month 9
Query!
Secondary outcome [98]
0
0
PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [98]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [98]
0
0
Month 9
Query!
Secondary outcome [99]
0
0
PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A
Query!
Assessment method [99]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.
Query!
Timepoint [99]
0
0
Month 9
Query!
Secondary outcome [100]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [100]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [100]
0
0
Month 9
Query!
Secondary outcome [101]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [101]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [101]
0
0
Month 9
Query!
Secondary outcome [102]
0
0
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [102]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A
Query!
Timepoint [102]
0
0
Month 9
Query!
Secondary outcome [103]
0
0
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [103]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [103]
0
0
Month 9
Query!
Secondary outcome [104]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [104]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [104]
0
0
Month 9
Query!
Secondary outcome [105]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [105]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [105]
0
0
Month 9
Query!
Secondary outcome [106]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A
Query!
Assessment method [106]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.
Query!
Timepoint [106]
0
0
Month 9
Query!
Secondary outcome [107]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [107]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [107]
0
0
Month 9
Query!
Secondary outcome [108]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [108]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [108]
0
0
Month 9
Query!
Secondary outcome [109]
0
0
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [109]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [109]
0
0
Month 9
Query!
Secondary outcome [110]
0
0
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [110]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [110]
0
0
Month 9
Query!
Secondary outcome [111]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [111]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [111]
0
0
Month 9
Query!
Secondary outcome [112]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [112]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [112]
0
0
Month 9
Query!
Secondary outcome [113]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B
Query!
Assessment method [113]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.
Query!
Timepoint [113]
0
0
Month 9
Query!
Secondary outcome [114]
0
0
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [114]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [114]
0
0
Month 9
Query!
Secondary outcome [115]
0
0
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [115]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [115]
0
0
Month 9
Query!
Secondary outcome [116]
0
0
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [116]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [116]
0
0
Month 9
Query!
Secondary outcome [117]
0
0
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [117]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [117]
0
0
Month 9
Query!
Secondary outcome [118]
0
0
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [118]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [118]
0
0
Month 9
Query!
Secondary outcome [119]
0
0
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [119]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [119]
0
0
Month 9
Query!
Secondary outcome [120]
0
0
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B
Query!
Assessment method [120]
0
0
In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.
Query!
Timepoint [120]
0
0
Month 9
Query!
Secondary outcome [121]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA
Query!
Assessment method [121]
0
0
The trough concentration of OCA in the cirrhotic participants who received 5 mg QD OCA was reported.
Query!
Timepoint [121]
0
0
Months 3, 6, 12, 24, and 48
Query!
Secondary outcome [122]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA
Query!
Assessment method [122]
0
0
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QD OCA was reported.
Query!
Timepoint [122]
0
0
Months 3, 6, 9, 12, and 24
Query!
Secondary outcome [123]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA
Query!
Assessment method [123]
0
0
The trough concentration of OCA in the cirrhotic participants who received 5 mg QOD OCA was reported.
Query!
Timepoint [123]
0
0
Months 6, 12, and 24
Query!
Secondary outcome [124]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA
Query!
Assessment method [124]
0
0
The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QOD OCA was reported.
Query!
Timepoint [124]
0
0
Months 3, 6, and 12
Query!
Secondary outcome [125]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA
Query!
Assessment method [125]
0
0
The trough concentration of OCA in the cirrhotic participants who received 5 mg QW OCA was reported.
Query!
Timepoint [125]
0
0
Months 6 and 12
Query!
Secondary outcome [126]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA
Query!
Assessment method [126]
0
0
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 5 QW QOD OCA was reported.
Query!
Timepoint [126]
0
0
Month 12
Query!
Secondary outcome [127]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA
Query!
Assessment method [127]
0
0
The trough concentration of OCA in the cirrhotic participants who received 5 mg Q2W OCA was reported.
Query!
Timepoint [127]
0
0
Months 6, 24, 36 and 48
Query!
Secondary outcome [128]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA
Query!
Assessment method [128]
0
0
The trough concentration of OCA in the non-cirrhotic participants who received 5 Q2W QOD OCA was reported.
Query!
Timepoint [128]
0
0
Months 3, 6, 12, 24, 36, and 48
Query!
Secondary outcome [129]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA
Query!
Assessment method [129]
0
0
The trough concentration of OCA in the cirrhotic participants who received 10 mg QD OCA was reported.
Query!
Timepoint [129]
0
0
Months 6, 9, 12, 24, 36, and 60
Query!
Secondary outcome [130]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA
Query!
Assessment method [130]
0
0
The trough concentration of OCA in the non-cirrhotic participants who received 10 QD QOD OCA was reported.
Query!
Timepoint [130]
0
0
Months 6, 9, 12, 24, and 36
Query!
Secondary outcome [131]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA
Query!
Assessment method [131]
0
0
Query!
Timepoint [131]
0
0
Months 3, 6, 9, 12, 24, 36, 48, and 60
Query!
Secondary outcome [132]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA
Query!
Assessment method [132]
0
0
In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg QOD OCA was reported.
Query!
Timepoint [132]
0
0
Month 12
Query!
Secondary outcome [133]
0
0
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA
Query!
Assessment method [133]
0
0
In Month 6, the trough concentration of OCA in the cirrhotic participants who received 10 mg Q2W OCA was reported.
Query!
Timepoint [133]
0
0
Month 6
Query!
Secondary outcome [134]
0
0
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA
Query!
Assessment method [134]
0
0
In Month 6, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg Q2W OCA was reported.
Query!
Timepoint [134]
0
0
Month 6
Query!
Eligibility
Key inclusion criteria
Key
1. Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases [AASLD] and the European Association for the Study of the Liver [EASL] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of =2 of the following 3 diagnostic factors:
* History of elevated Alkaline phosphatase levels for at least 6 months
* Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
* Liver biopsy consistent with PBC
2. A mean total bilirubin >ULN and =5x ULN and/or a mean ALP >3x ULN
3. Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for =3 months prior to Day 0
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. History or presence of other concomitant liver diseases including:
* Hepatitis C virus infection
* Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
* Primary sclerosing cholangitis (PSC)
* Alcoholic liver disease
* Definite autoimmune liver disease or overlap hepatitis
* Nonalcoholic steatohepatitis (NASH)
* Gilbert's Syndrome
2. Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
* History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria
* Cirrhosis with complications, including history (within the past 12 months) or presence of:
* Variceal bleed
* Uncontrolled ascites
* Encephalopathy
* Spontaneous bacterial peritonitis
* Known or suspected HCC
* Prior transjugular intrahepatic portosystemic shunt procedure
* Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 µmol/L)
3. Mean total bilirubin >5x ULN
4. Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
5. Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
6. If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
7. Known history of human immunodeficiency virus infection
8. Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
9. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
10. History of alcohol abuse or other substance abuse within 1 year prior to Day 0
11. Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study
12. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
13. History of known or suspected clinically significant hypersensitivity to OCA or any of its components
14. UDCA naïve (unless contraindicated)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/12/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
23/12/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
334
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Department of Gastroenterology & Hepatology, Nepean Hospital - Kingswood
Query!
Recruitment hospital [3]
0
0
Gallipoli Medical Research Foundation - Brisbane
Query!
Recruitment hospital [4]
0
0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [5]
0
0
Flinders Medical Centre - Adelaide
Query!
Recruitment hospital [6]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [7]
0
0
St. Vincent's Hospital Melbourne - Fitzroy
Query!
Recruitment hospital [8]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [9]
0
0
Fiona Stanley Hospital, Gastroenterology Department - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
4120 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
5042 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [7]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [8]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [9]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Mississippi
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Utah
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Virginia
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Buenos Aires
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Cordoba
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Santa Fe
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Vienna
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Antwerp
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Vlaams-Brabant
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Bruxelles
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Ghent
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Bahia
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Campinas
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Distrito Federal Brazil
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Goias
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Maranhao
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Minas Gerais
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Rio Grande Do Sul
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Salvador
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Sao Paulo
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Rio de Janeiro
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Sofia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Manitoba
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Chile
Query!
State/province [48]
0
0
V Región
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Aarhus C
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
København Ø
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
Odense
Query!
Country [52]
0
0
Estonia
Query!
State/province [52]
0
0
Harju
Query!
Country [53]
0
0
Estonia
Query!
State/province [53]
0
0
Tartu
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Helsinki
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Turku,
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Lille
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Pessac Cedex
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Hessen
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Lower Saxony
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
QLD
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Berlin
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Hamburg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Heidelberg
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Leipzig
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Munich
Query!
Country [67]
0
0
Hong Kong
Query!
State/province [67]
0
0
Pokfulam
Query!
Country [68]
0
0
Hong Kong
Query!
State/province [68]
0
0
Shatin
Query!
Country [69]
0
0
Hong Kong
Query!
State/province [69]
0
0
Tuen Mun, New Territories
Query!
Country [70]
0
0
Hong Kong
Query!
State/province [70]
0
0
Hong Kong
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Bekescsaba
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Budapest
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Debrecen
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Nazareth Elit
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Beer Sheva
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Haifa
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Jerusalem
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Petach Tikva
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Ramat-Gan
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Tel-Aviv
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Cagliari
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Ancona
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Bologna
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Florence
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Milano
Query!
Country [86]
0
0
Italy
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Modena
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Italy
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Italy
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Italy
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Rome
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Seo-gu
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Nottingham
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Funding & Sponsors
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Name
Intercept Pharmaceuticals
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Summary
Brief summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
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Trial website
https://clinicaltrials.gov/study/NCT02308111
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Trial related presentations / publications
Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
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Public notes
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Contacts
Principal investigator
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Erik Ness, MD
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Intercept Pharmaceuticals
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT02308111/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT02308111/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02308111
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