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NCT02639247 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 333
- Enrollment target
NCT02639247: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02639247 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 333 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02639247, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 333 participants
- Enrollment target
Study Summary
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Interventions
- DRUG SOF/VEL/VOX
- DRUG SOF/VEL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2017-01-18 |
| Phase | Phase 3 |
What the finished NCT02639247 record still lists
NCT02639247 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which SOF/VEL/VOX is the first listed.
NCT02639247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02639247 about?
NCT02639247 is a clinical study titled "Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor". The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antivi...
What is the current status of trial NCT02639247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2015-12-23. Estimated completion is 2017-01-18.
What interventions are being tested in trial NCT02639247?
The interventions under investigation include: SOF/VEL/VOX (DRUG), SOF/VEL (DRUG).
Who is sponsoring clinical trial NCT02639247?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02639247's enrollment target sits among peer trials
333 1061st of 2000 higher than 940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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