Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
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Official title
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.
Study identification
- NCT ID
- NCT02174276
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2014 (Actual)
- Primary completion
- Feb 17, 2016 (Actual)
- Completion
- May 30, 2018 (Actual)
- Last update posted
- Jun 4, 2019
2014 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | — | — |
| Kaiser Permanente | Sacramento | California | — | — |
| Research and Education, Inc. | San Diego | California | — | — |
| Kaiser Permanente San Francisco | San Francisco | California | — | — |
| Silicon Valley Research Institute | San Jose | California | — | — |
| The Queen's Medical Center | Honolulu | Hawaii | — | — |
| Digestive Disease Associates, PA | Baltimore | Maryland | — | — |
| Tufts Medical Center | Boston | Massachusetts | — | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | — | — |
| Xiaoli Ma, PC | Philadelphia | Pennsylvania | — | — |
| Virginia Commonwealth University | Richmond | Virginia | — | — |
| Kaiser Permanente | Springfield | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02174276, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2019 · Synced Nov 15, 2026
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