CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
Vesatolimod +1 moredrug
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.

Search/NCT02166047
NCT02166047Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B

Gilead Sciences·interventional·Posted Jun 18, 2014·Updated Oct 14, 2020

In Brief

A Phase 2 clinical trial evaluating Vesatolimod and Placebo for Chronic Hepatitis B. Completed, enrolled 162 participants across 23 sites in 6 countries.

Detailed Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, Italy, Netherlands, New Zealand, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 18, 2014
Enrollment StartJun 30, 2014
Primary CompletionMay 11, 2016
Study CompletionOct 20, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.0 years ago

Interventions

Vesatolimoddrug

Vesatolimod tablet administered orally

Placebodrug

Placebo to match vesatolimod tablet administered orally