CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 181 enrolled
Drug / intervention
TAF +3 moredrug
Likely dose
TAF 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02836249
NCT02836249Phase 3Completed
CompareCT.gov

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 Positive, Chronic Hepatitis B

Gilead Sciences·interventional·Posted Jul 18, 2016·Updated Oct 15, 2024

In Brief

A Phase 3 clinical trial evaluating TAF, TDF, and 2 other interventions for HBV and Chronic HBV Infection. Completed, enrolled 181 participants across 25 sites.

Detailed 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)-positive chronic hepatitis B virus (HBV) infection in China.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHBV, Chronic HBV Infection
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 18, 2016
Enrollment StartJun 19, 2015
Primary CompletionMar 21, 2017
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.0 years ago

Interventions

TAFdrug

TAF 25 mg tablet administered orally once daily

TDFdrug

TDF 300 mg tablet administered orally once daily

TAF Placebodrug

TAF placebo tablet administered orally once daily

TDF Placebodrug

TDF placebo tablet administered orally once daily