At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
TAFdrug
Likely dose
Not stated in 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 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and/or Hepatic Impairment
In Brief
A Phase 2 clinical trial evaluating TAF for Chronic Hepatitis B. Completed, enrolled 124 participants across 30 sites in 8 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, Hong Kong, Italy, New Zealand, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2017
Primary CompletionMar 2019
Study CompletionSep 2020
TodayJul 2026
First PostedJun 8, 2017
Enrollment StartJun 29, 2017
Primary CompletionMar 27, 2019
Study CompletionSep 4, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.1 years ago
Interventions
TAFdrug
Tablet administered orally once daily