Trials / Completed
CompletedNCT02201940
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 741 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL | 400/100 mg FDC tablet administered orally once daily |
| DRUG | Placebo | Tablet administered orally once daily |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-06-01
- Completion
- 2015-09-01
- First posted
- 2014-07-28
- Last updated
- 2018-11-15
- Results posted
- 2016-09-16
Locations
80 sites across 9 countries: United States, Belgium, Canada, China, France, Germany, Italy, Puerto Rico, United Kingdom
Source: ClinicalTrials.gov record NCT02201940. Inclusion in this directory is not an endorsement.