Trials / Completed
CompletedNCT01896193
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
| DRUG | RBV | Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-04-01
- Completion
- 2014-06-01
- First posted
- 2013-07-11
- Last updated
- 2015-05-29
- Results posted
- 2015-04-17
Locations
16 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT01896193. Inclusion in this directory is not an endorsement.