Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir; Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)

• Subjects chronically infected with HCV genotype 4 (Phase 2b only)

• HCV RNA viral load of ≥ 10*5* IU/mL at screening

• BMI of 18 - 35 kg/m² at screening

Exclusion Criteria:

• Cirrhosis (Phase 2a only)

• Decompensated cirrhosis (Phase 2b)

• Co-infection with HBV or HIV

• Hepatocellular carcinoma

• Prior treatment with anti-HCV drugs