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NCT02174276 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT02174276: Completed Phase 2 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
NCT02174276 is a Phase 2 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 195 participants, below the 280-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02174276, a Phase 2 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (\> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
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 |
What the finished NCT02174276 record still lists
NCT02174276 is an interventional study that assigns participants to a tested intervention. The registered 195 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 (30% lower).
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.
NCT02174276 names 20 study sites across 11 states, led by California, Ontario, Virginia.
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.
What interventions are being tested in trial NCT02174276?
The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), GS-4774 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02174276?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT02174276's enrollment target sits among peer trials
195 5th of 14 higher than 10 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.
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