Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferons; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL

• Not co-infected with HIV

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• History of any other clinically significant chronic liver disease

• Pregnant or nursing female or male with pregnant female partner

• History of significant drug allergy to nucleoside/nucleotide analogs.

• Participation in a clinical study within 3 months prior to first dose

• Positive result for significant drug use at Screening