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NCT02579382 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
A Phase 2 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT02579382: Completed Phase 2 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
NCT02579382 is a Phase 2 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 192 participants, below the 280-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579382, a Phase 2 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (\> 19 vs ≤ 19 IU/L for females; \> 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TDF
- DRUG Vesatolimod
Study Locations (20)
Other
- - Kowloon
- - Bologna
- - Milan
- - Pisa
- - San Giovanni Rotondo
- - Daegu
- - Seoul
- - Dalin
- - Kaohsiung City
California
- - Los Angeles
- - Palo Alto
- - San Diego
- - San Francisco
Hawaii
- - Honolulu
Maryland
- - Catonsville
Massachusetts
- - Boston
New York
- - Flushing
Pennsylvania
- - Philadelphia
Ontario
- - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2019-05-03 |
| Phase | Phase 2 |
What the finished NCT02579382 record still lists
NCT02579382 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 280-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02579382 names 20 study sites across 9 states, led by Other, California, Hawaii.
Frequently Asked Questions
What is clinical trial NCT02579382 about?
NCT02579382 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated". 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.
What is the current status of trial NCT02579382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2015-11-10. Estimated completion is 2019-05-03.
What conditions does trial NCT02579382 study?
This clinical trial studies the following conditions: Chronic Hepatitis B.
What interventions are being tested in trial NCT02579382?
The interventions under investigation include: Placebo (DRUG), TDF (DRUG), Vesatolimod (DRUG).
Who is sponsoring clinical trial NCT02579382?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02579382 being conducted?
This trial has 20 study locations across California, Hawaii, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02579382's enrollment target sits among peer trials
192 6th of 14 higher than 9 of 14 other Chronic Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
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