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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03633227
Registration number
NCT03633227
Ethics application status
Date submitted
8/04/2018
Date registered
16/08/2018
Date last updated
6/09/2022
Titles & IDs
Public title
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
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Scientific title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
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Secondary ID [1]
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747-401
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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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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0
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0
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Other infectious diseases
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Inflammatory and Immune System
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0
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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0
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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) - Participants will initiate treatment with OCA 5 milligrams (mg) tablets orally once weekly. At Week 12, if there are no safety concerns, the dose will be up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose will be considered. At each titration visit, the participants will start the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration will be OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration will be 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).
Placebo Comparator: Placebo - Participants will receive OCA matching placebo orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).
Treatment: Drugs: Obeticholic Acid (OCA)
OCA will be administered per dose and schedule specified in the arm description.
Treatment: Drugs: Placebo
OCA matching placebo will be administered per the schedule specified in the arm description.
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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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Maximum Observed Concentration (Cmax) of Total OCA at Week 12
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Assessment method [1]
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Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
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Timepoint [1]
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Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
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Primary outcome [2]
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Time to Maximum Concentration (Tmax) of Total OCA at Week 12
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Assessment method [2]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [2]
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0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
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Primary outcome [3]
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Trough Concentration (Ctrough) of Total OCA at Week 12
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Assessment method [3]
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Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [3]
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24 hours post-dose at Week 12
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Primary outcome [4]
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Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12
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Assessment method [4]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
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Timepoint [4]
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0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
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Primary outcome [5]
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Cmax of Total OCA at Week 18
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Assessment method [5]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [5]
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0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
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Primary outcome [6]
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Tmax of Total OCA at Week 18
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Assessment method [6]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [6]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
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Primary outcome [7]
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0
Ctrough of Total OCA at Week 18
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Assessment method [7]
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0
Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [7]
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0
24 hours post-dose at Week 18
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Primary outcome [8]
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0
AUC0-24h of Total OCA at Week 18
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Assessment method [8]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
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Timepoint [8]
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0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
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Primary outcome [9]
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Cmax of Total OCA at Week 24
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Assessment method [9]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [9]
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Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
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Primary outcome [10]
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0
Tmax of Total OCA at Week 24
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Assessment method [10]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [10]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
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Primary outcome [11]
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0
Ctrough of Total OCA at Week 24
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Assessment method [11]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [11]
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0
24 hours post-dose at Week 24
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Primary outcome [12]
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0
AUC0-24h of Total OCA at Week 24
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Assessment method [12]
0
0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [12]
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0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
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Primary outcome [13]
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Cmax of Total OCA at Week 30
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Assessment method [13]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [13]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
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Primary outcome [14]
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0
Tmax of Total OCA at Week 30
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Assessment method [14]
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0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [14]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
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Primary outcome [15]
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0
Ctrough of Total OCA at Week 30
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Assessment method [15]
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0
Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
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Timepoint [15]
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0
24 hours post-dose at Week 30
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Primary outcome [16]
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0
AUC0-24h of Total OCA at Week 30
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Assessment method [16]
0
0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [16]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
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Primary outcome [17]
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0
Cmax of Total OCA at Week 48
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Assessment method [17]
0
0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Query!
Timepoint [17]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [18]
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0
Tmax of Total OCA at Week 48
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Assessment method [18]
0
0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Query!
Timepoint [18]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [19]
0
0
Ctrough of Total OCA at Week 48
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Assessment method [19]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Query!
Timepoint [19]
0
0
24 hours post-dose at Week 48
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Primary outcome [20]
0
0
AUC0-24h of Total OCA at Week 48
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Assessment method [20]
0
0
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [20]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
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Primary outcome [21]
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0
Cmax of Unconjugated OCA at Week 12
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Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [22]
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0
Tmax of Unconjugated OCA at Week 12
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Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
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Primary outcome [23]
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0
Ctrough of Unconjugated OCA at Week 12
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Assessment method [23]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
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Timepoint [23]
0
0
24 hours post-dose at Week 12
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Primary outcome [24]
0
0
AUC0-24h of Unconjugated OCA at Week 12
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Assessment method [24]
0
0
AUC0-24 was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [24]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [25]
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0
Cmax of Unconjugated OCA at Week 18
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Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [26]
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0
Tmax of Unconjugated OCA at Week 18
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Assessment method [26]
0
0
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Timepoint [26]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [27]
0
0
Ctrough of Unconjugated OCA at Week 18
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Assessment method [27]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
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Timepoint [27]
0
0
24 hours post-dose at Week 18
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Primary outcome [28]
0
0
AUC0-24h of Unconjugated OCA at Week 18
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Assessment method [28]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [28]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
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Primary outcome [29]
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0
Cmax of Unconjugated OCA at Week 24
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Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
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Primary outcome [30]
0
0
Tmax of Unconjugated OCA at Week 24
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Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [31]
0
0
Ctrough of Unconjugated OCA at Week 24
Query!
Assessment method [31]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Query!
Timepoint [31]
0
0
24 hours post-dose at Week 24
Query!
Primary outcome [32]
0
0
AUC0-24h of Unconjugated OCA at Week 24
Query!
Assessment method [32]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [32]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [33]
0
0
Cmax of Unconjugated OCA at Week 30
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Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [34]
0
0
Tmax of Unconjugated OCA at Week 30
Query!
Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [35]
0
0
Ctrough of Unconjugated OCA at Week 30
Query!
Assessment method [35]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Query!
Timepoint [35]
0
0
24 hours post-dose at Week 30
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Primary outcome [36]
0
0
AUC0-24h of Unconjugated OCA at Week 30
Query!
Assessment method [36]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [36]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [37]
0
0
Cmax of Unconjugated OCA at Week 48
Query!
Assessment method [37]
0
0
Query!
Timepoint [37]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [38]
0
0
Tmax of Unconjugated OCA at Week 48
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [39]
0
0
Ctrough of Unconjugated OCA at Week 48
Query!
Assessment method [39]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
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Timepoint [39]
0
0
24 hours post-dose at Week 48
Query!
Primary outcome [40]
0
0
AUC0-24h of Unconjugated OCA at Week 48
Query!
Assessment method [40]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [40]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [41]
0
0
Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12
Query!
Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [42]
0
0
Tmax of Glyco-OCA at Week 12
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [43]
0
0
Ctrough of Glyco-OCA at Week 12
Query!
Assessment method [43]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Query!
Timepoint [43]
0
0
24 hours post-dose at Week 12
Query!
Primary outcome [44]
0
0
AUC0-24h of Glyco-OCA at Week 12
Query!
Assessment method [44]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [44]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [45]
0
0
Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12
Query!
Assessment method [45]
0
0
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [45]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [46]
0
0
Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12
Query!
Assessment method [46]
0
0
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [46]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [47]
0
0
Cmax of Glyco-OCA at Week 18
Query!
Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [48]
0
0
Tmax of Glyco-OCA at Week 18
Query!
Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [49]
0
0
Ctrough of Glyco-OCA at Week 18
Query!
Assessment method [49]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Query!
Timepoint [49]
0
0
24 hours post-dose at Week 18
Query!
Primary outcome [50]
0
0
AUC0-24h of Glyco-OCA at Week 18
Query!
Assessment method [50]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [50]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [51]
0
0
MRAUC of Glyco-OCA at Week 18
Query!
Assessment method [51]
0
0
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [51]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [52]
0
0
MRCmax of Glyco-OCA at Week 18
Query!
Assessment method [52]
0
0
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [52]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [53]
0
0
Cmax of Glyco-OCA at Week 24
Query!
Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [54]
0
0
Tmax of Glyco-OCA at Week 24
Query!
Assessment method [54]
0
0
Query!
Timepoint [54]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [55]
0
0
Ctrough of Glyco-OCA at Week 24
Query!
Assessment method [55]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Query!
Timepoint [55]
0
0
24 hours post-dose at Week 24
Query!
Primary outcome [56]
0
0
AUC0-24h of Glyco-OCA at Week 24
Query!
Assessment method [56]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [56]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [57]
0
0
MRAUC of Glyco-OCA at Week 24
Query!
Assessment method [57]
0
0
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [57]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [58]
0
0
MRCmax of Glyco-OCA at Week 24
Query!
Assessment method [58]
0
0
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [58]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [59]
0
0
Cmax of Glyco-OCA at Week 30
Query!
Assessment method [59]
0
0
Query!
Timepoint [59]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [60]
0
0
Tmax of Glyco-OCA at Week 30
Query!
Assessment method [60]
0
0
Query!
Timepoint [60]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [61]
0
0
Ctrough of Glyco-OCA at Week 30
Query!
Assessment method [61]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Query!
Timepoint [61]
0
0
24 hours post-dose at Week 30
Query!
Primary outcome [62]
0
0
AUC0-24h of Glyco-OCA at Week 30
Query!
Assessment method [62]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [62]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [63]
0
0
MRAUC of Glyco-OCA at Week 30
Query!
Assessment method [63]
0
0
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [63]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [64]
0
0
MRCmax of Glyco-OCA at Week 30
Query!
Assessment method [64]
0
0
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [64]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [65]
0
0
Cmax of Glyco-OCA at Week 48
Query!
Assessment method [65]
0
0
Query!
Timepoint [65]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [66]
0
0
Tmax of Glyco-OCA at Week 48
Query!
Assessment method [66]
0
0
Query!
Timepoint [66]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [67]
0
0
Ctrough of Glyco-OCA at Week 48
Query!
Assessment method [67]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Query!
Timepoint [67]
0
0
24 hours post-dose at Week 48
Query!
Primary outcome [68]
0
0
AUC0-24h of Glyco-OCA at Week 48
Query!
Assessment method [68]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [68]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [69]
0
0
MRAUC of Glyco-OCA at Week 48
Query!
Assessment method [69]
0
0
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [69]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [70]
0
0
MRCmax of Glyco-OCA at Week 48
Query!
Assessment method [70]
0
0
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [70]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [71]
0
0
Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12
Query!
Assessment method [71]
0
0
Query!
Timepoint [71]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [72]
0
0
Tmax of Tauro-OCA at Week 12
Query!
Assessment method [72]
0
0
Query!
Timepoint [72]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [73]
0
0
Ctrough of Tauro-OCA at Week 12
Query!
Assessment method [73]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Query!
Timepoint [73]
0
0
24 hours post-dose at Week 12
Query!
Primary outcome [74]
0
0
AUC0-24h of Tauro-OCA at Week 12
Query!
Assessment method [74]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [74]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [75]
0
0
MRAUC of Tauro-OCA at Week 12
Query!
Assessment method [75]
0
0
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [75]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [76]
0
0
MRCmax of Tauro-OCA at Week 12
Query!
Assessment method [76]
0
0
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [76]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [77]
0
0
Cmax of Tauro-OCA at Week 18
Query!
Assessment method [77]
0
0
Query!
Timepoint [77]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [78]
0
0
Tmax of Tauro-OCA at Week 18
Query!
Assessment method [78]
0
0
Query!
Timepoint [78]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [79]
0
0
Ctrough of Tauro-OCA at Week 18
Query!
Assessment method [79]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Query!
Timepoint [79]
0
0
24 hours post-dose at Week 18
Query!
Primary outcome [80]
0
0
AUC0-24h of Tauro-OCA at Week 18
Query!
Assessment method [80]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [80]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [81]
0
0
MRAUC of Tauro-OCA at Week 18
Query!
Assessment method [81]
0
0
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [81]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [82]
0
0
MRCmax of Tauro-OCA at Week 18
Query!
Assessment method [82]
0
0
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [82]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [83]
0
0
Cmax of Tauro-OCA at Week 24
Query!
Assessment method [83]
0
0
Query!
Timepoint [83]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [84]
0
0
Tmax of Tauro-OCA at Week 24
Query!
Assessment method [84]
0
0
Query!
Timepoint [84]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [85]
0
0
Ctrough of Tauro-OCA at Week 24
Query!
Assessment method [85]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Query!
Timepoint [85]
0
0
24 hours post-dose at Week 24
Query!
Primary outcome [86]
0
0
AUC0-24h of Tauro-OCA at Week 24
Query!
Assessment method [86]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [86]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [87]
0
0
MRAUC of Tauro-OCA at Week 24
Query!
Assessment method [87]
0
0
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [87]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [88]
0
0
MRCmax of Tauro-OCA at Week 24
Query!
Assessment method [88]
0
0
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [88]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [89]
0
0
Cmax of Tauro-OCA at Week 30
Query!
Assessment method [89]
0
0
Query!
Timepoint [89]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [90]
0
0
Tmax of Tauro-OCA at Week 30
Query!
Assessment method [90]
0
0
Query!
Timepoint [90]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [91]
0
0
Ctrough of Tauro-OCA at Week 30
Query!
Assessment method [91]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Query!
Timepoint [91]
0
0
24 hours post-dose at Week 30
Query!
Primary outcome [92]
0
0
AUC0-24h of Tauro-OCA at Week 30
Query!
Assessment method [92]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [92]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [93]
0
0
MRAUC of Tauro-OCA at Week 30
Query!
Assessment method [93]
0
0
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [93]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [94]
0
0
MRCmax of Tauro-OCA at Week 30
Query!
Assessment method [94]
0
0
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [94]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [95]
0
0
Cmax of Tauro-OCA at Week 48
Query!
Assessment method [95]
0
0
Query!
Timepoint [95]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [96]
0
0
Tmax of Tauro-OCA at Week 48
Query!
Assessment method [96]
0
0
Query!
Timepoint [96]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [97]
0
0
Ctrough of Tauro-OCA at Week 48
Query!
Assessment method [97]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Query!
Timepoint [97]
0
0
24 hours post-dose at Week 48
Query!
Primary outcome [98]
0
0
AUC0-24h of Tauro-OCA at Week 48
Query!
Assessment method [98]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [98]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [99]
0
0
MRAUC of Tauro-OCA at Week 48
Query!
Assessment method [99]
0
0
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [99]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [100]
0
0
MRCmax of Tauro-OCA at Week 48
Query!
Assessment method [100]
0
0
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Query!
Timepoint [100]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [101]
0
0
Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12
Query!
Assessment method [101]
0
0
Query!
Timepoint [101]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [102]
0
0
Tmax of OCA-glucuronide at Week 12
Query!
Assessment method [102]
0
0
Query!
Timepoint [102]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [103]
0
0
Ctrough of OCA-glucuronide at Week 12
Query!
Assessment method [103]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Query!
Timepoint [103]
0
0
24 hours post-dose at Week 12
Query!
Primary outcome [104]
0
0
AUC0-24h of OCA-glucuronide at Week 12
Query!
Assessment method [104]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [104]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [105]
0
0
MRAUC of OCA-glucuronide at Week 12
Query!
Assessment method [105]
0
0
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [105]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [106]
0
0
MRCmax of OCA-glucuronide at Week 12
Query!
Assessment method [106]
0
0
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Query!
Timepoint [106]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Query!
Primary outcome [107]
0
0
Cmax of OCA-glucuronide at Week 18
Query!
Assessment method [107]
0
0
Query!
Timepoint [107]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [108]
0
0
Tmax of OCA-glucuronide at Week 18
Query!
Assessment method [108]
0
0
Query!
Timepoint [108]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [109]
0
0
Ctrough of OCA-glucuronide at Week 18
Query!
Assessment method [109]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Query!
Timepoint [109]
0
0
24 hours post-dose at Week 18
Query!
Primary outcome [110]
0
0
AUC0-24h of OCA-glucuronide at Week 18
Query!
Assessment method [110]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [110]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [111]
0
0
MRAUC of OCA-glucuronide at Week 18
Query!
Assessment method [111]
0
0
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [111]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [112]
0
0
MRCmax of OCA-glucuronide at Week 18
Query!
Assessment method [112]
0
0
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Query!
Timepoint [112]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Query!
Primary outcome [113]
0
0
Cmax of OCA-glucuronide at Week 24
Query!
Assessment method [113]
0
0
Query!
Timepoint [113]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [114]
0
0
Tmax of OCA-glucuronide at Week 24
Query!
Assessment method [114]
0
0
Query!
Timepoint [114]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [115]
0
0
Ctrough of OCA-glucuronide at Week 24
Query!
Assessment method [115]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Query!
Timepoint [115]
0
0
24 hours post-dose at Week 24
Query!
Primary outcome [116]
0
0
AUC0-24h of OCA-glucuronide at Week 24
Query!
Assessment method [116]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [116]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [117]
0
0
MRAUC of OCA-glucuronide at Week 24
Query!
Assessment method [117]
0
0
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [117]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [118]
0
0
MRCmax of OCA-glucuronide at Week 24
Query!
Assessment method [118]
0
0
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Query!
Timepoint [118]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Query!
Primary outcome [119]
0
0
Cmax of OCA-glucuronide at Week 30
Query!
Assessment method [119]
0
0
Query!
Timepoint [119]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [120]
0
0
Tmax of OCA-glucuronide at Week 30
Query!
Assessment method [120]
0
0
Query!
Timepoint [120]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [121]
0
0
Ctrough of OCA-glucuronide at Week 30
Query!
Assessment method [121]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Query!
Timepoint [121]
0
0
24 hours post-dose at Week 30
Query!
Primary outcome [122]
0
0
AUC0-24h of OCA-glucuronide at Week 30
Query!
Assessment method [122]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [122]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [123]
0
0
MRAUC of OCA-glucuronide at Week 30
Query!
Assessment method [123]
0
0
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [123]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [124]
0
0
MRCmax of OCA-glucuronide at Week 30
Query!
Assessment method [124]
0
0
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Query!
Timepoint [124]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Query!
Primary outcome [125]
0
0
Cmax of OCA-glucuronide at Week 48
Query!
Assessment method [125]
0
0
Query!
Timepoint [125]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [126]
0
0
Tmax of OCA-glucuronide at Week 48
Query!
Assessment method [126]
0
0
Query!
Timepoint [126]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [127]
0
0
Ctrough of OCA-glucuronide at Week 48
Query!
Assessment method [127]
0
0
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Query!
Timepoint [127]
0
0
24 hours post-dose at Week 48
Query!
Primary outcome [128]
0
0
AUC0-24h of OCA-glucuronide at Week 48
Query!
Assessment method [128]
0
0
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Query!
Timepoint [128]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [129]
0
0
MRAUC of OCA-glucuronide at Week 48
Query!
Assessment method [129]
0
0
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Query!
Timepoint [129]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [130]
0
0
MRCmax of OCA-glucuronide at Week 48
Query!
Assessment method [130]
0
0
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Query!
Timepoint [130]
0
0
Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Query!
Primary outcome [131]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [131]
0
0
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
An SAE was any AE that results in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in in-patient hospitalization or prolonged an existing hospitalization, was a congenital anomaly/birth defect, or was an important medical event that could jeopardize the participant or could have required medical intervention to prevent one of the outcomes listed above.
TEAE was defined as any AE if it met one or more of the following criteria: 1) An AE started on or after the first study drug dose and within 30 days after the last dose of study drug, 2) An AE occurred prior to the first study drug dose that worsens (increase in grade) after the first study drug dose.
Query!
Timepoint [131]
0
0
Baseline up to approximately 3 years
Query!
Secondary outcome [1]
0
0
Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [1]
0
0
The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) [total bilirubin (mg/deciliter [dL])] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.
Query!
Timepoint [1]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [2]
0
0
Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [2]
0
0
The MELD-Na scoring system is used to assess the severity of chronic liver disease in the participants with an initial MELD(i) score greater than 11. MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and sodium. The MELD-Na score is re-calculated as follows:
MELD-Na = MELD(i) + 1.32*(137-Na) - [0.033*MELD(i)*(137-Na)]. MELD score ranges from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
The MELD(i) score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) [total bilirubin (mg/deciliter [dL])] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.
Query!
Timepoint [2]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [3]
0
0
Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [3]
0
0
The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and INR) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant.
Query!
Timepoint [3]
0
0
Baseline, Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [4]
0
0
Number of Participants by Child-Pugh Score Component Category (Ascites Categories)
Query!
Assessment method [4]
0
0
Number of participants with Child-Pugh component - ascites categories of none, mild, and moderate-severe has been reported. The ascites categories were defined per investigator's discretion.
Query!
Timepoint [4]
0
0
Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [5]
0
0
Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories)
Query!
Assessment method [5]
0
0
Number of participants with Child-Pugh component - prothrombin time (measured as INR) in categories of <1.7, 1.7 - 2.3, and >2.3 has been reported.
Query!
Timepoint [5]
0
0
Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [6]
0
0
Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories)
Query!
Assessment method [6]
0
0
Number of participants with Child-Pugh component - serum albumin levels in categories of >35 gram per liter (g/L), 28-35 g/L, or <28 g/L has been reported.
Query!
Timepoint [6]
0
0
Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [7]
0
0
Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories)
Query!
Assessment method [7]
0
0
Number of participants with Child-Pugh component - total bilirubin levels in categories of <34 micromole per liter (µmol/L), 34-50 µmol/L, and >50 µmol/L has been reported.
Query!
Timepoint [7]
0
0
Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [8]
0
0
Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories)
Query!
Assessment method [8]
0
0
Number of participants with Child-Pugh component - Hepatic encephalopathy in categories of Grade 0, Grade 1 or 2, and Grade 3 and 4 has been reported.
Grade 0: normal consciousness, normal personality, normal neurological examination, normal electroencephalogram.
Grade 1: restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5 cycles, per second (cps) waves.
Grade 2: lethargic, time-disoriented, inappropriate, asterixis, ataxia, slow triphasic waves.
Grade 3: somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity, slower waves.
Grade 4: unrousable coma, no personality/behavior, decerebrate, slow 2-3 cps delta activity.
Query!
Timepoint [8]
0
0
Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [9]
0
0
Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [10]
0
0
Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [11]
0
0
Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [12]
0
0
Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [13]
0
0
Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [14]
0
0
Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [15]
0
0
Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [16]
0
0
Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [17]
0
0
Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [18]
0
0
Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Query!
Secondary outcome [19]
0
0
Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Assessment method [19]
0
0
Total bile acids (micromole [µM]) = total ursodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM.
Query!
Timepoint [19]
0
0
Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Secondary outcome [20]
0
0
Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Assessment method [20]
0
0
Total endogenous bile acids (µM) = total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in µM.
Query!
Timepoint [20]
0
0
Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Secondary outcome [21]
0
0
Change From Baseline in 7a-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Secondary outcome [22]
0
0
Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Query!
Eligibility
Key inclusion criteria
1. A definite or probable diagnosis of PBC (consistent with American Association for the
Study of Liver Diseases [AASLD] and European Association for the Study of the Liver
[EASL] Practice Guidelines, defined as having =2 of the following 3 diagnostic
factors:
- History of elevated alkaline phosphatase (ALP) levels for at least 6 months
- Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer
(=1:80), PBC specific antibodies (anti-glycoprotein 210 [GP210] and/or
anti-SP100) and/or antibodies against the major M2 components (E2 component of
mitochondrial pyruvate dehydrogenase complex [PDC-E2], 2-oxo-glutaric acid
dehydrogenase complex)
- Liver biopsy consistent with PBC (collected at any time prior to Screening)
2. Evidence of cirrhosis including at least one of the following:
- Biopsy results consistent with PBC Stage 4
- Liver stiffness as assessed by Transient Elastography (TE) Median Value =16.9
kilopascals (kPa)
- Clinical evidence in the absence of acute liver failure consistent with cirrhosis
including: gastroesophageal varices, ascites, radiological evidence of cirrhosis
(nodular liver or enlargement of portal vein and splenomegaly)
- Combined low platelet count (<140,000/cubic millimeter [mm^3]) with
- persistent decrease in serum albumin, or
- elevation in prothrombin time/international normalized ratio (INR) (not due
to antithrombotic agent use), or
- elevated bilirubin (2*upper limit of normal [ULN])
3. Satisfy the criteria of the modified Child-Pugh (CP) classification for hepatic
impairment during Screening:
- Moderate: CP-B (Scores 7 to 9) or
- Severe: CP-C (Scores 10 to 12)
4. Model of end-stage liver disease (MELD) score of 6 to 24 at Screening
5. Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for =3 months)
prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for =3 months)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
2. History of liver transplant or organ transplant
3. History of alcohol or drug abuse within 12 months prior to Screening
4. Hepatic encephalopathy (as defined by a West Haven score of =2
5. History or presence of other concomitant liver diseases including:
- Hepatitis C virus infection and ribonucleic acid (RNA) positive
- Active hepatitis B infection; however, participants 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
- Alcoholic liver disease
- Definite autoimmune liver disease or overlap hepatitis
- Gilbert's Syndrome
6. In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic
function prior to randomization
Other inclusion/exclusion criteria may apply.
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
Terminated
Query!
Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/07/2021
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment outside Australia
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United States of America
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California
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Florida
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Maryland
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Michigan
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Missouri
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Ohio
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Pennsylvania
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Texas
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Mendoza
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Argentina
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Pilar
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Argentina
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Rosario
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Leuven
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Brazil
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Belo Horizonte
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Brazil
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Rio Grande
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Brazil
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São Paulo
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Canada
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Toronto
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Estonia
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Tallinn
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Estonia
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Tartu
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Germany
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Leipzig
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Hungary
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Bekescsaba
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Italy
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MB
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Italy
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Modena
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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State/province [33]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Intercept Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the
pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to
severe hepatic impairment over a 48-week treatment period. Participants who have completed
their 48-week double blind treatment period will continue double-blind treatment until all
randomized participants have completed their 48-week treatment period and the database for
that period is locked. An open-label extension study in which all participants receive OCA
will be considered following review of blinded safety and PK data.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03633227
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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.
Vilstrup H, Amodio P, Bajaj J, Cordoba J, Ferenci P, Mullen KD, Weissenborn K, Wong P. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014 Aug;60(2):715-35. doi: 10.1002/hep.27210. Epub 2014 Jul 8. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Steven Shiff, M.D.
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Address
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Intercept Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03633227
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