Trials / Completed
CompletedNCT02166047
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vesatolimod | Vesatolimod tablet administered orally |
| DRUG | Placebo | Placebo to match vesatolimod tablet administered orally |
Timeline
- Start date
- 2014-06-30
- Primary completion
- 2016-05-11
- Completion
- 2016-10-20
- First posted
- 2014-06-18
- Last updated
- 2020-10-14
- Results posted
- 2020-09-02
Locations
23 sites across 6 countries: United States, Canada, Italy, Netherlands, New Zealand, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02166047. Inclusion in this directory is not an endorsement.