At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 426 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.
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
In Brief
A Phase 3 clinical trial evaluating TAF, TDF, and 2 other interventions for HBeAg-negative Chronic Hepatitis B. Completed, enrolled 426 participants across 105 sites in 17 countries.
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)-negative chronic hepatitis B virus (HBV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHBeAg-negative Chronic Hepatitis B
CountriesAustralia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Poland, Romania, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartSep 2013
Primary CompletionSep 2015
Study CompletionAug 2022
TodayJul 2026
First PostedSep 12, 2013
Enrollment StartSep 12, 2013
Primary CompletionSep 30, 2015
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.8 years ago
Interventions
TAFdrug
25 mg tablet administered orally once daily
TDFdrug
300 mg tablet administered orally once daily
TAF Placebodrug
Tablet administered orally once daily
TDF Placebodrug
Tablet administered orally once daily