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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/NCT03180619
Registration number
NCT03180619
Ethics application status
Date submitted
6/06/2017
Date registered
8/06/2017
Date last updated
27/09/2021
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)
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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
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Secondary ID [1]
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2016-004625-16
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Secondary ID [2]
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GS-US-320-4035
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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:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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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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Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24
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Assessment method [1]
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The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Week 24
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Primary outcome [3]
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Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24
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Assessment method [3]
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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.
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Timepoint [3]
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Week 24
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Secondary outcome [1]
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Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48
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Assessment method [1]
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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.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96
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Assessment method [2]
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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.
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Timepoint [2]
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Week 96
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Secondary outcome [3]
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Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48
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Assessment method [3]
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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.
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Timepoint [3]
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Week 48
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Secondary outcome [4]
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Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96
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Assessment method [4]
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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.
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Timepoint [4]
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Week 96
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 48
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Secondary outcome [7]
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Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 96
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Secondary outcome [8]
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Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
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Assessment method [8]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [8]
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Baseline, Week 24
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Secondary outcome [9]
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Percent Change From Baseline in Hip BMD at Week 48
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Assessment method [9]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [9]
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Baseline, Week 48
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Secondary outcome [10]
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Percent Change From Baseline in Hip BMD at Week 96
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Assessment method [10]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [10]
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Baseline, Week 96
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Secondary outcome [11]
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Percent Change From Baseline in Spine BMD at Week 24
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Assessment method [11]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [11]
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Baseline, Week 24
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Secondary outcome [12]
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Percent Change From Baseline in Spine BMD at Week 48
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Assessment method [12]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [12]
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Baseline, Week 48
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Secondary outcome [13]
0
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Percent Change From Baseline in Spine BMD at Week 96
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Assessment method [13]
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Percent change = Change from baseline at a postbaseline visit/baseline * 100%.
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Timepoint [13]
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Baseline, Week 96
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Secondary outcome [14]
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Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48
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Assessment method [14]
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The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
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Timepoint [14]
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Weeks 48
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Secondary outcome [15]
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Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96
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Assessment method [15]
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The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.
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Timepoint [15]
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Weeks 96
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Secondary outcome [16]
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Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= Lower Limit of Detection [LLOD]) at Week 24
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Assessment method [16]
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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.
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Timepoint [16]
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Week 24
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Secondary outcome [17]
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Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= LLOD) at Week 48
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Assessment method [17]
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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.
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Timepoint [17]
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Week 48
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Secondary outcome [18]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (= LLOD) at Week 96
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Assessment method [18]
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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.
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Timepoint [18]
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Week 96
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Secondary outcome [19]
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Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24
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Assessment method [19]
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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.
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Timepoint [19]
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Week 24
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Secondary outcome [20]
0
0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48
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Assessment method [20]
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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.
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Timepoint [20]
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Weeks 48
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Secondary outcome [21]
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0
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96
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Assessment method [21]
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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.
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Timepoint [21]
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Weeks 96
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Secondary outcome [22]
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Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24
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Assessment method [22]
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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.
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Timepoint [22]
0
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Week 24
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Secondary outcome [23]
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Percentage of Participants With Serological Response: Loss of HBsAg at Week 48
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Assessment method [23]
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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.
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Timepoint [23]
0
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Week 48
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Secondary outcome [24]
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Percentage of Participants With Serological Response: Loss of HBsAg at Week 96
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Assessment method [24]
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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.
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Timepoint [24]
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Week 96
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Secondary outcome [25]
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Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24
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Assessment method [25]
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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.
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Timepoint [25]
0
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Week 24
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Secondary outcome [26]
0
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Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48
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Assessment method [26]
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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.
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Timepoint [26]
0
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Week 48
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Secondary outcome [27]
0
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Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96
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Assessment method [27]
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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.
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Timepoint [27]
0
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Week 96
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Secondary outcome [28]
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Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24
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Assessment method [28]
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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.
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Timepoint [28]
0
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Week 24
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Secondary outcome [29]
0
0
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48
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Assessment method [29]
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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.
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Timepoint [29]
0
0
Week 48
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Secondary outcome [30]
0
0
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96
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Assessment method [30]
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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.
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Timepoint [30]
0
0
Week 96
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Secondary outcome [31]
0
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Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24
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Assessment method [31]
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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.
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Timepoint [31]
0
0
Week 24
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Secondary outcome [32]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48
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Assessment method [32]
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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.
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Timepoint [32]
0
0
Week 48
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Secondary outcome [33]
0
0
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96
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Assessment method [33]
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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.
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Timepoint [33]
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Week 96
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Secondary outcome [34]
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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
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Assessment method [34]
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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.
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Timepoint [34]
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Week 24
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Secondary outcome [35]
0
0
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria
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Assessment method [35]
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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.
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Timepoint [35]
0
0
Week 48
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Secondary outcome [36]
0
0
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria
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Assessment method [36]
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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.
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Timepoint [36]
0
0
Week 96
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Secondary outcome [37]
0
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Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria
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Assessment method [37]
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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.
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Timepoint [37]
0
0
Week 24
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Secondary outcome [38]
0
0
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria
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Assessment method [38]
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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.
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Timepoint [38]
0
0
Week 48
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Secondary outcome [39]
0
0
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria
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Assessment method [39]
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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.
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Timepoint [39]
0
0
Week 96
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Secondary outcome [40]
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0
Change From Baseline in FibroTest® Score at Week 24
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Assessment method [40]
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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.
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Timepoint [40]
0
0
Baseline, Week 24
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Secondary outcome [41]
0
0
Change From Baseline in FibroTest® Score at Week 48
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Assessment method [41]
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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.
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Timepoint [41]
0
0
Baseline, Week 48
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Secondary outcome [42]
0
0
Change From Baseline in FibroTest® Score at Week 96
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Assessment method [42]
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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.
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Timepoint [42]
0
0
Week 96
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Secondary outcome [43]
0
0
Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24
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Assessment method [43]
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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.
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Timepoint [43]
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Baseline, Week 24
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Secondary outcome [44]
0
0
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48
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Assessment method [44]
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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.
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Timepoint [44]
0
0
Baseline, Week 48
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Secondary outcome [45]
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0
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96
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Assessment method [45]
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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.
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Timepoint [45]
0
0
Baseline, Week 96
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Secondary outcome [46]
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0
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24
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Assessment method [46]
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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.
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Timepoint [46]
0
0
Baseline, Week 24
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Secondary outcome [47]
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0
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48
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Assessment method [47]
0
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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.
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Timepoint [47]
0
0
Baseline, Week 48
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Secondary outcome [48]
0
0
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96
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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.
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Timepoint [48]
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0
Baseline, Week 96
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
29/06/2017
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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
4/09/2020
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Michigan
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Washington
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Country [4]
0
0
Canada
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State/province [4]
0
0
Calgary
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0
0
Canada
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State/province [5]
0
0
Montreal
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0
0
Canada
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0
0
Toronto
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0
0
Canada
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State/province [7]
0
0
Vancouver
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Country [8]
0
0
Hong Kong
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State/province [8]
0
0
NT
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Country [9]
0
0
Hong Kong
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State/province [9]
0
0
Kowloon
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Country [10]
0
0
Hong Kong
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State/province [10]
0
0
Tai Po
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Country [11]
0
0
Italy
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0
0
Milan
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Country [12]
0
0
Italy
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State/province [12]
0
0
Bologna
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Country [13]
0
0
Korea, Republic of
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State/province [13]
0
0
Busan
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0
0
Korea, Republic of
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State/province [14]
0
0
Seoul
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0
0
New Zealand
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State/province [15]
0
0
Auckland
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Country [16]
0
0
Taiwan
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State/province [16]
0
0
Changhua
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Country [17]
0
0
Taiwan
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State/province [17]
0
0
Chiayi City
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Country [18]
0
0
Taiwan
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State/province [18]
0
0
Kaohsiung City
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Country [19]
0
0
Taiwan
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State/province [19]
0
0
Kaohsiung
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Country [20]
0
0
Taiwan
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State/province [20]
0
0
Taichung
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Country [21]
0
0
Taiwan
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State/province [21]
0
0
Taipei
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Country [22]
0
0
Taiwan
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State/province [22]
0
0
Taoyuan City
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Country [23]
0
0
United Kingdom
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State/province [23]
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0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03180619
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
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Address
0
0
Gilead Sciences
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
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0
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Phone
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0
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Fax
0
0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03180619
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