Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Chronic genotype 2 HCV-infection

• Male or female, age ≥ 20 years

• Body weight ≥ 40 kg

• HCV RNA ≥ 10,000 IU/mL at screening

Exclusion Criteria:

• Current or prior history of clinically significant illness other than HCV

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of a non-HCV etiology

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)