NCT02862548

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TAF	Tablet administered orally
DRUG	TDF	Tablet administered orally
DRUG	Other approved antivirals	Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice

Timeline

• Start date: 2016-09-16
• Primary completion: 2018-02-08
• Completion: 2021-05-05
• First posted: 2016-08-11
• Last updated: 2022-06-08
• Results posted: 2019-02-26

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study