At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 192 enrolled
Drug / intervention
TDF +2 moredrug
Likely dose
TDF 300 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 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
In Brief
A Phase 2 clinical trial evaluating TDF, Vesatolimod, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 192 participants across 21 sites in 8 countries.
Detailed Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
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
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartNov 2015
Primary CompletionJan 2017
Study CompletionMay 2019
TodayJul 2026
First PostedOct 19, 2015
Enrollment StartNov 10, 2015
Primary CompletionJan 16, 2017
Study CompletionMay 3, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago
Interventions
TDFdrug
300 mg tablets administered orally once daily
Vesatolimoddrug
Tablets administered orally once a week (every 7 days) for 12 doses
Placebodrug
Placebo administered orally once a week (every 7 days) for 12 doses