At a glance
ClinicalIndex Comparison Record- ✓Documented chronic HBV infection prior to liver transplant
- ✓Liver transplant recipient (single or dual liver-kidney, from deceased or living donor) ≥12 weeks before screening
- ✓Currently on TDF alone or combined with other approved HBV antivirals for prophylaxis or treatment
- ✓On approved HBV oral antiviral therapy for ≥12 weeks post-transplant with HBV DNA <LLOQ at screening
- ✕Multi-organ transplant including heart or lung (liver-kidney dual transplant is allowed)
- ✕History of de novo or recurrent HCC post-transplant
- ✕Histological evidence of unresolved transplant rejection
- ✕Uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or decompensated cirrhosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating TAF, TDF, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Tablet administered orally
Tablet administered orally
Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice