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NCT02201901 · ClinicalTrials.gov registry record · Phase 3
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 268
- Enrollment target
NCT02201901: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT02201901 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 268 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201901, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 268 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Interventions
- DRUG RBV
- DRUG SOF/VEL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
What the finished NCT02201901 record still lists
NCT02201901 is an interventional study that assigns participants to a tested intervention. The registered 268 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.
NCT02201901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201901 about?
NCT02201901 is a clinical study titled "Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis". The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child...
What is the current status of trial NCT02201901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 268 participants. The study started on 2014-07. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02201901?
The interventions under investigation include: RBV (DRUG), SOF/VEL (DRUG).
Who is sponsoring clinical trial NCT02201901?
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 NCT02201901's enrollment target sits among peer trials
268 1222nd of 2000 higher than 779 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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