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NCT02979613 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
A Phase 3 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
- 20
- Study locations
NCT02979613: Completed Phase 3 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
NCT02979613 is a Phase 3 study of Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 490 participants, above the 259-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02979613, a Phase 3 study of Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
Primary Outcome
The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who: 1. Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or 2. Did not have on-treatment HBV DNA data available in the Week 48 analysis window and * Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or * Discontinu
Conditions Studied
Interventions
- DRUG TAF
- DRUG TDF
- DRUG TDF Placebo
- DRUG TAF Placebo
Study Locations (20)
California
- - Los Angeles
- - Palo Alto
- - Pasadena
- - San Diego
- - San Francisco
- - San Jose
New York
- - Flushing
- - Flushing
- - New York
- - New York
Other
- - Edmonton
- - Toronto
- - Vancouver
Pennsylvania
- - Philadelphia
- - Philadelphia
Maryland
- - Baltimore
Massachusetts
- - Boston
Michigan
- - Novi
Tennessee
- - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2016-12-29 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 3 |
What the finished NCT02979613 record still lists
NCT02979613 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 259-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (89% higher).
The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 4 interventions - of which TAF is the first listed.
NCT02979613 names 20 study sites across 9 states, led by California, New York, Other.
Frequently Asked Questions
What is clinical trial NCT02979613 about?
NCT02979613 is a clinical study titled "Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed". The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
What is the current status of trial NCT02979613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2016-12-29. Estimated completion is 2020-01-30.
What conditions does trial NCT02979613 study?
This clinical trial studies the following conditions: Chronic Hepatitis B.
What interventions are being tested in trial NCT02979613?
The interventions under investigation include: TAF (DRUG), TDF (DRUG), TDF Placebo (DRUG), TAF Placebo (DRUG).
Who is sponsoring clinical trial NCT02979613?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02979613 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Michigan, 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 NCT02979613's enrollment target sits among peer trials
490 4th of 14 higher than 11 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
-
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
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Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
ACTIVE NOT RECRUITING · Phase 3
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Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
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