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NCT01909804 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT01909804: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT01909804 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 323 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01909804, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Interventions
- DRUG SOF
- DRUG RBV
- DRUG VEL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01909804 record still lists
NCT01909804 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 3 interventions - of which SOF is the first listed.
NCT01909804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01909804 about?
NCT01909804 is a clinical study titled "Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection". The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
What is the current status of trial NCT01909804?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2013-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01909804?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), VEL (DRUG).
Who is sponsoring clinical trial NCT01909804?
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 NCT01909804's enrollment target sits among peer trials
323 150th of 2000 higher than 1,851 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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