Trials / Completed
CompletedNCT02346721
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 111 (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/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL | 400/100 mg tablet administered orally once daily |
Timeline
- Start date
- 2015-02-23
- Primary completion
- 2016-03-23
- Completion
- 2016-06-15
- First posted
- 2015-01-27
- Last updated
- 2018-11-16
- Results posted
- 2017-05-03
Locations
61 sites across 9 countries: United States, Belgium, Canada, France, Germany, Hong Kong, Italy, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02346721. Inclusion in this directory is not an endorsement.