Trials / Completed
CompletedNCT02671500
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
A Phase 3, Multicenter, Open-Label 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
- 375 (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 treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL | SOF/VEL (400/100 mg) FDC tablet administered orally once daily |
Timeline
- Start date
- 2016-04-19
- Primary completion
- 2018-01-05
- Completion
- 2018-03-27
- First posted
- 2016-02-02
- Last updated
- 2019-01-08
- Results posted
- 2019-01-08
Locations
38 sites across 5 countries: China, Malaysia, Singapore, Thailand, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02671500. Inclusion in this directory is not an endorsement.