NCT02836236

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection in China.

Detailed description

This study GS-US-320-0108 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study (NCT01940341) before China was able to participate. Therefore, this registration only includes the China cohorts as they were not part of the main study analysis. Data for China cohorts were analyzed separately after the main study analysis was completed.

Conditions

• HBV
• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	TAF	TAF 25 mg tablet administered orally once daily
DRUG	TDF	TDF 300 mg tablet administered orally once daily
DRUG	TAF Placebo	TAF placebo tablet administered orally once daily
DRUG	TDF Placebo	TDF placebo tablet administered orally once daily

Timeline

• Start date: 2015-06-19
• Primary completion: 2017-04-05
• Completion: 2023-09-18
• First posted: 2016-07-18
• Last updated: 2024-10-02
• Results posted: 2018-04-18

Locations

29 sites across 1 country: China

Regulatory

• FDA-regulated drug study