Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Male or female, ages 18 to 65 years

• Documented chronic HCV infection, genotype 1a or 1b

• Treatment-naïve

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding

• Infection with non-genotype 1 HCV

• Previous treatment for HCV infection

• HIV or HBV positive

• Any medical contraindication to Peg-IFN or RBV therapy

• History of any other known cause of liver disease