At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 875 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-Positive, Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating TAF, TDF, and 2 other interventions for HBeAg-positive Chronic Hepatitis B. Completed, enrolled 875 participants across 160 sites in 19 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)-positive chronic hepatitis B virus (HBV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHBeAg-positive Chronic Hepatitis B
CountriesAustralia, Bulgaria, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedSep 2013
Primary CompletionNov 2015
Study CompletionOct 2022
TodayJul 2026
First PostedSep 12, 2013
Enrollment StartSep 11, 2013
Primary CompletionNov 16, 2015
Study CompletionOct 13, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 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