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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
NCT02174276 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Tenofovir disoproxil fumarate
- BIOLOGICAL GS-4774
Study Locations (20)
California
- Stanford University Medical Center — Palo Alto
- Kaiser Permanente — Sacramento
- Research and Education, Inc. — San Diego
- Kaiser Permanente San Francisco — San Francisco
- Silicon Valley Research Institute — San Jose
Ontario
- Toronto General Hospital-The University Health Network — Toronto
- Toronto Liver Centre — Toronto
- Toronto Western Hospital-The University Health Network — Toronto
Virginia
- Virginia Commonwealth University — Richmond
- Kaiser Permanente — Springfield
British Columbia
- Gordon & Leslie Diamond Health Care Centre — Vancouver
- Liver and Intestinal Research Center — Vancouver
Other
- Aou-S.Orsola-Malpighi - Universita Degli Studi Di — Bologna
- Azienda Ospedaliero-Universitaria di Parma — Parma
Hawaii
- The Queen's Medical Center — Honolulu
Maryland
- Digestive Disease Associates, PA — Baltimore
Massachusetts
- Tufts Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2014-07-24 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02174276
The ClinicalTrials.gov registry entry for NCT02174276 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 2 interventions — of which Tenofovir disoproxil fumarate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02174276 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Ontario, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02174276 about?
NCT02174276 is a clinical study titled "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". 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 pa...
What is the current status of trial NCT02174276?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2014-07-24. Estimated completion is 2018-05-30.
What conditions does trial NCT02174276 study?
This clinical trial studies the following conditions: Chronic Hepatitis B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02174276?
The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), GS-4774 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02174276?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02174276 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.
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