NCT01940341

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen

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: 426 (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.

Detailed description

Study GS-US-320-0108 is a multi-center clinical trial, planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort was registered separately (NCT02836236) on ClinicalTrials.gov as the China cohort will not be part of the main study analysis.

Conditions

• HBeAg-negative Chronic Hepatitis B

Interventions

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

Timeline

• Start date: 2013-09-12
• Primary completion: 2015-09-30
• Completion: 2022-08-31
• First posted: 2013-09-12
• Last updated: 2023-09-25
• Results posted: 2017-03-30

Locations

105 sites across 17 countries: United States, Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Poland, Romania, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom