NCT02862548
Completed
Phase 2
A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Subjects With Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
ConditionsChronic Hepatitis B
Overview
- Phase
- Phase 2
- Intervention
- TAF
- Conditions
- Chronic Hepatitis B
- Sponsor
- Gilead Sciences
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- •Documented evidence of chronic HBV infection prior to transplantation
- •Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
- •Liver Transplant ≥ 12 weeks prior to screening
- •Maintained on TDF alone or in combination with other approved antivirals for HBV prophylaxis or treatment
- •Have been on approved HBV oral antiviral (OAV) treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA \< lower limit of quantification (LLOQ) at screening
- •Screening estimated glomerular filtration rate using the chronic kidney disease epidemiology collaboration (eGFR_CKD-EPI) \< 90 ml/min/1.73m\^2
- •Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Women considered of child bearing potential must have a negative serum pregnancy test at Screening and a negative urine test at Baseline before dosing
- •Must be willing and able to comply with all study requirements
Exclusion Criteria
- •Multi-organ transplant that includes heart or lung recipient (participants who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
- •Participants with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
- •Histological evidence of unresolved transplant rejection
- •Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
- •Participants meeting any of the following laboratory parameters at screening:
- •Alanine aminotransferase (ALT) \> 10 × the upper limit of normal (ULN)
- •International normalized ratio (INR) \> 1.5 × ULN unless the participant is stable on anticoagulant regimen affecting INR
- •Albumin \< 3.0 g/dL
- •Direct bilirubin ≥ 4 × ULN
- •Platelet count \< 50,000/mL
Arms & Interventions
TAF
TAF 25 mg once daily for 48 weeks
Intervention: TAF
TDF-Containing Regimens
TDF alone or in combination with other approved antivirals per local practice for 48 weeks
Intervention: TDF
TDF-Containing Regimens
TDF alone or in combination with other approved antivirals per local practice for 48 weeks
Intervention: Other approved antivirals
Optional Treatment Extension Phase
After Week 48, participants will be eligible to receive TAF 25 mg once daily for an additional 144 weeks.
Intervention: TAF
Outcomes
Primary Outcomes
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Time Frame: Baseline, Week 24
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
Time Frame: Week 24
Secondary Outcomes
- Percent Change From Baseline in Spine BMD at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Hip BMD at Week 48(Baseline, Week 48)
- Percent Change From Baseline in Spine BMD at Week 48(Baseline, Week 48)
- Change From Baseline in Serum Creatinine at Week 24(Baseline, Week 24)
- Change From Baseline in Serum Creatinine at Week 48(Baseline, Week 48)
- Change From Baseline in Serum eGFR_CKD-EPI at Week 48(Baseline, Week 48)
- Percentage of Participants With HBV DNA < 20 IU/mL at Week 48(Week 48)
- Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24(Baseline, Week 24)
Study Sites (1)
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