At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 490 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 Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed
In Brief
A Phase 3 clinical trial evaluating TAF, TDF, and 2 other interventions for Chronic Hepatitis B. Completed, enrolled 490 participants across 39 sites in 8 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, Hong Kong, Italy, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionSep 2018
Study CompletionJan 2020
TodayJul 2026
First PostedDec 1, 2016
Enrollment StartDec 29, 2016
Primary CompletionSep 10, 2018
Study CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.6 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