Trials / Completed
CompletedNCT01910636
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sofosbuvir | Sofosbuvir 400 mg tablet administered orally once daily |
| DRUG | RBV | Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg) |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-03-01
- Completion
- 2014-06-01
- First posted
- 2013-07-29
- Last updated
- 2015-03-24
- Results posted
- 2015-03-24
Locations
19 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01910636. Inclusion in this directory is not an endorsement.