Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03180619
Registration number
NCT03180619
Ethics application status
Date submitted
6/06/2017
Date registered
8/06/2017
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
Query!
Scientific title
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and/or Hepatic Impairment
Query!
Secondary ID [1]
0
0
2016-004625-16
Query!
Secondary ID [2]
0
0
GS-US-320-4035
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TAF
Experimental: Part A (Renal Impairment): Moderate or Severe Renal Impairment - Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), will switch to tenofovir alafenamide (TAF) and receive TAF 25 milligram (mg) tablet once daily orally for 96 weeks.
Experimental: Part A (Renal Impairment): End Stage Renal Disease - Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks.
Experimental: Part B: Hepatic Impairment - Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks.
Treatment: Drugs: TAF
Tablet administered orally once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
Query!
Assessment method [1]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
Query!
Timepoint [1]
0
0
Week 24
Query!
Primary outcome [2]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
Query!
Assessment method [2]
0
0
Treatment-emergent AEs were defined as:
* Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug;
* Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug;
* Any AEs leading to premature discontinuation of study drug.
The most severe graded AE from all tests was counted for each participant.
Query!
Timepoint [2]
0
0
Week 24
Query!
Primary outcome [3]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24
Query!
Assessment method [3]
0
0
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.
The most severe graded abnormality from all tests was counted for each participant.
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48
Query!
Assessment method [1]
0
0
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96
Query!
Assessment method [2]
0
0
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
Query!
Timepoint [2]
0
0
Week 96
Query!
Secondary outcome [3]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48
Query!
Assessment method [3]
0
0
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.
The most severe graded abnormality from all tests was counted for each participant.
Query!
Timepoint [3]
0
0
Week 48
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96
Query!
Assessment method [4]
0
0
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
Query!
Timepoint [4]
0
0
Week 96
Query!
Secondary outcome [5]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24
Query!
Assessment method [5]
0
0
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min = eGFRCG = 59 mL/min Severe renal impairment= 15 mL/min = eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
Query!
Timepoint [5]
0
0
Baseline, Week 24
Query!
Secondary outcome [6]
0
0
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48
Query!
Assessment method [6]
0
0
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min = eGFRCG = 59 mL/min Severe renal impairment= 15 mL/min = eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Query!
Timepoint [6]
0
0
Baseline, Week 48
Query!
Secondary outcome [7]
0
0
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96
Query!
Assessment method [7]
0
0
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.
Moderate renal impairment= 30 mL/min = eGFRCG = 59 mL/min Severe renal impairment= 15 mL/min = eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Query!
Timepoint [7]
0
0
Baseline, Week 96
Query!
Secondary outcome [8]
0
0
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Query!
Assessment method [8]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [8]
0
0
Baseline, Week 24
Query!
Secondary outcome [9]
0
0
Percent Change From Baseline in Hip BMD at Week 48
Query!
Assessment method [9]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [9]
0
0
Baseline, Week 48
Query!
Secondary outcome [10]
0
0
Percent Change From Baseline in Hip BMD at Week 96
Query!
Assessment method [10]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [10]
0
0
Baseline, Week 96
Query!
Secondary outcome [11]
0
0
Percent Change From Baseline in Spine BMD at Week 24
Query!
Assessment method [11]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [11]
0
0
Baseline, Week 24
Query!
Secondary outcome [12]
0
0
Percent Change From Baseline in Spine BMD at Week 48
Query!
Assessment method [12]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [12]
0
0
Baseline, Week 48
Query!
Secondary outcome [13]
0
0
Percent Change From Baseline in Spine BMD at Week 96
Query!
Assessment method [13]
0
0
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
Query!
Timepoint [13]
0
0
Baseline, Week 96
Query!
Secondary outcome [14]
0
0
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48
Query!
Assessment method [14]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
Query!
Timepoint [14]
0
0
Weeks 48
Query!
Secondary outcome [15]
0
0
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96
Query!
Assessment method [15]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
Query!
Timepoint [15]
0
0
Weeks 96
Query!
Secondary outcome [16]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= Lower Limit of Detection [LLOD]) at Week 24
Query!
Assessment method [16]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target detected (= LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Query!
Timepoint [16]
0
0
Week 24
Query!
Secondary outcome [17]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= LLOD) at Week 48
Query!
Assessment method [17]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target detected (= LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.
Query!
Timepoint [17]
0
0
Week 48
Query!
Secondary outcome [18]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= LLOD) at Week 96
Query!
Assessment method [18]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target detected (= LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.
Query!
Timepoint [18]
0
0
Week 96
Query!
Secondary outcome [19]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24
Query!
Assessment method [19]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target not detected (\< LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.
Query!
Timepoint [19]
0
0
Week 24
Query!
Secondary outcome [20]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48
Query!
Assessment method [20]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target not detected (\< LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.
Query!
Timepoint [20]
0
0
Weeks 48
Query!
Secondary outcome [21]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96
Query!
Assessment method [21]
0
0
The percentage of participants with HBV DNA \< 20 IU/mL and target not detected (\< LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.
Query!
Timepoint [21]
0
0
Weeks 96
Query!
Secondary outcome [22]
0
0
Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24
Query!
Assessment method [22]
0
0
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [22]
0
0
Week 24
Query!
Secondary outcome [23]
0
0
Percentage of Participants With Serological Response: Loss of HBsAg at Week 48
Query!
Assessment method [23]
0
0
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [23]
0
0
Week 48
Query!
Secondary outcome [24]
0
0
Percentage of Participants With Serological Response: Loss of HBsAg at Week 96
Query!
Assessment method [24]
0
0
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [24]
0
0
Week 96
Query!
Secondary outcome [25]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24
Query!
Assessment method [25]
0
0
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [25]
0
0
Week 24
Query!
Secondary outcome [26]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48
Query!
Assessment method [26]
0
0
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [26]
0
0
Week 48
Query!
Secondary outcome [27]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96
Query!
Assessment method [27]
0
0
HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [27]
0
0
Week 96
Query!
Secondary outcome [28]
0
0
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24
Query!
Assessment method [28]
0
0
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [28]
0
0
Week 24
Query!
Secondary outcome [29]
0
0
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48
Query!
Assessment method [29]
0
0
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [29]
0
0
Week 48
Query!
Secondary outcome [30]
0
0
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96
Query!
Assessment method [30]
0
0
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.
Query!
Timepoint [30]
0
0
Week 96
Query!
Secondary outcome [31]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24
Query!
Assessment method [31]
0
0
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [31]
0
0
Week 24
Query!
Secondary outcome [32]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48
Query!
Assessment method [32]
0
0
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [32]
0
0
Week 48
Query!
Secondary outcome [33]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96
Query!
Assessment method [33]
0
0
HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Query!
Timepoint [33]
0
0
Week 96
Query!
Secondary outcome [34]
0
0
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria
Query!
Assessment method [34]
0
0
Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [34]
0
0
Week 24
Query!
Secondary outcome [35]
0
0
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria
Query!
Assessment method [35]
0
0
Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [35]
0
0
Week 48
Query!
Secondary outcome [36]
0
0
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria
Query!
Assessment method [36]
0
0
Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [36]
0
0
Week 96
Query!
Secondary outcome [37]
0
0
Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria
Query!
Assessment method [37]
0
0
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [37]
0
0
Week 24
Query!
Secondary outcome [38]
0
0
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria
Query!
Assessment method [38]
0
0
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [38]
0
0
Week 48
Query!
Secondary outcome [39]
0
0
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria
Query!
Assessment method [39]
0
0
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: = 43 U/L for males aged 18 to \< 69 years and = 35 U/L for males aged = 69 years; = 34 U/L for females aged 18 to \< 69 years and = 32 U/L for females aged = 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.
Query!
Timepoint [39]
0
0
Week 96
Query!
Secondary outcome [40]
0
0
Change From Baseline in FibroTest® Score at Week 24
Query!
Assessment method [40]
0
0
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
Query!
Timepoint [40]
0
0
Baseline, Week 24
Query!
Secondary outcome [41]
0
0
Change From Baseline in FibroTest® Score at Week 48
Query!
Assessment method [41]
0
0
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Query!
Timepoint [41]
0
0
Baseline, Week 48
Query!
Secondary outcome [42]
0
0
Change From Baseline in FibroTest® Score at Week 96
Query!
Assessment method [42]
0
0
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Query!
Timepoint [42]
0
0
Week 96
Query!
Secondary outcome [43]
0
0
Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24
Query!
Assessment method [43]
0
0
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Query!
Timepoint [43]
0
0
Baseline, Week 24
Query!
Secondary outcome [44]
0
0
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48
Query!
Assessment method [44]
0
0
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Query!
Timepoint [44]
0
0
Baseline, Week 48
Query!
Secondary outcome [45]
0
0
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96
Query!
Assessment method [45]
0
0
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
Query!
Timepoint [45]
0
0
Baseline, Week 96
Query!
Secondary outcome [46]
0
0
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24
Query!
Assessment method [46]
0
0
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Query!
Timepoint [46]
0
0
Baseline, Week 24
Query!
Secondary outcome [47]
0
0
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48
Query!
Assessment method [47]
0
0
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Query!
Timepoint [47]
0
0
Baseline, Week 48
Query!
Secondary outcome [48]
0
0
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96
Query!
Assessment method [48]
0
0
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
Query!
Timepoint [48]
0
0
Baseline, Week 96
Query!
Eligibility
Key inclusion criteria
Key
All Participants (Parts A and B):
* Adult male or non-pregnant female individuals
* Documented evidence of chronic HBV infection
* Alanine aminotransferase (ALT) = 10 × upper limit of normal (ULN)
Part A Only (renal impairment):
* Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid [DNA] < lower limit of quantitation [LLOQ]) for = 6 months prior to screening
* All individuals must have HBV DNA < 20 International units per milliliter (IU/mL) at screening by central laboratory
* Both Hepatitis B e-Antigen (HBeAg) positive and negative individuals are eligible to participate
* Moderate renal impairment (30 milliliters per minute [mL/min] = estimated glomerular filtration rate by the cockcroft-gault formula [eGFRcg] = 59 mL/min), severe renal impairment (15 mL/min = eGFRcg < 30 mL/min) or end stage renal disease (ESRD) (eGFR < 15 mL/min) maintained on hemodialysis (HD)
* Stable renal function (for participants with moderate or severe impairment): serum creatinine measured at least once within three months prior to screening. The measurement difference between the value measured within three months prior to screening versus the screening value must be = 25% of the screening value
Part B Only (hepatic impairment):
* Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for = 6 months prior to screening
* All individuals must have HBV DNA < 20 IU/mL at screening by central laboratory
* Both HBeAg positive and negative individuals are eligible to participate
* Child-pugh-turcotte (CPT) score of 7-12 (inclusive) OR a past history of CPT score = 7 and any CPT score = 12 at screening
* eGFRCG = 30 mL/min using the Cockcroft-Gault equation
Key
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
All Individuals (Parts A & B):
* Women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
* Prior Interferon (IFN) use within 6 months of screening
* Evidence of hepatocellular carcinoma
* Received solid organ or bone marrow transplant
* Significant cardiovascular, pulmonary, or neurological disease
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Individuals under evaluation for possible malignancy are not eligible
* Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
* Known hypersensitivity to study drugs, metabolites, or formulation excipients
* Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
Part A Only (Renal Impairment):
* Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
* Abnormal hematological and biochemical parameters, including:
* Hemoglobin < 9 grams per deciliter (g/dL)
* Absolute neutrophil count < 750/cubic millimeter (mm^3)
* Platelets = 50,000/mm^3
* Aspartate aminotransferase (AST) > 10 × ULN
* Albumin < 3.0 g/dL
* Total bilirubin > 2.5 × ULN
* International normalized ratio of prothrombin time (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
* Individuals with ESRD (i.e. eGFRcg < 15 mL/min) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)
Part B Only (Hepatic Impairment):
* Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt [TIPS])
* History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of screening
* Grade 2 hepatic encephalopathy at screening
* Model for end-stage liver disease (MELD) score = 30
* Abnormal hematological and biochemical parameters, including
* Absolute neutrophil count < 750/mm^3
* Platelets < 30,000/mm^3
* Hemoglobin < 8.0 g/dL
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised 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
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/06/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
4/09/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
124
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Michigan
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Washington
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Calgary
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Montreal
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Toronto
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Vancouver
Query!
Country [8]
0
0
Hong Kong
Query!
State/province [8]
0
0
NT
Query!
Country [9]
0
0
Hong Kong
Query!
State/province [9]
0
0
Kowloon
Query!
Country [10]
0
0
Hong Kong
Query!
State/province [10]
0
0
Tai Po
Query!
Country [11]
0
0
Italy
Query!
State/province [11]
0
0
Milan
Query!
Country [12]
0
0
Italy
Query!
State/province [12]
0
0
Bologna
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Busan
Query!
Country [14]
0
0
Korea, Republic of
Query!
State/province [14]
0
0
Seoul
Query!
Country [15]
0
0
New Zealand
Query!
State/province [15]
0
0
Auckland
Query!
Country [16]
0
0
Taiwan
Query!
State/province [16]
0
0
Changhua
Query!
Country [17]
0
0
Taiwan
Query!
State/province [17]
0
0
Chiayi City
Query!
Country [18]
0
0
Taiwan
Query!
State/province [18]
0
0
Kaohsiung City
Query!
Country [19]
0
0
Taiwan
Query!
State/province [19]
0
0
Kaohsiung
Query!
Country [20]
0
0
Taiwan
Query!
State/province [20]
0
0
Taichung
Query!
Country [21]
0
0
Taiwan
Query!
State/province [21]
0
0
Taipei
Query!
Country [22]
0
0
Taiwan
Query!
State/province [22]
0
0
Taoyuan City
Query!
Country [23]
0
0
United Kingdom
Query!
State/province [23]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03180619
Query!
Trial related presentations / publications
Lim YS, Lin CY, Heo J, Bae H, Chuang WL, Hui AJ, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT442]. The Digital International Liver Congress (ILC); 2020 27-29 August. Janssen HLA, Lampertico P, Chen CY, Heo J, Fournier C, Ahn SH, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT429]. The Digital International Liver Congress (ILC); 2020 27-29 August. Lim YS, Lampertico P, Bae H, Chuang WL, Heo J, Huang YH, et al. Switching From Tenofovir Disoproxil Fumarate or Other Oral Antiviral Therapy to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week 24 Efficacy and Safety Results From a Phase 2 Open-label Study [Poster 501]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA. Janssen HLA, Lim YS, Gane EJ, Fournier C, Ahn SH, Tsang O, et al. Efficacy and Safety of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week 24 Results From a Phase 2 Open-label Study [Poster 483]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
18 months after study completion
Query!
Available to whom?
A secured external environment with username, password, and RSA code.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/19/NCT03180619/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/19/NCT03180619/SAP_002.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Lim YS, Lin CY, Heo J, Bae H, Chuang WL, Hui AJ, e...
[
More Details
]
Journal
Janssen HLA, Lampertico P, Chen CY, Heo J, Fournie...
[
More Details
]
Journal
Lim YS, Lampertico P, Bae H, Chuang WL, Heo J, Hua...
[
More Details
]
Journal
Janssen HLA, Lim YS, Gane EJ, Fournier C, Ahn SH, ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03180619