Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

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

Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

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

Details

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

Criteria

Key Inclusion Criteria:

• Patients chronically infected with hepatitis C virus (HCV) genotype 1

• HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening

• Treatment naive

Key Exclusion Criteria:

• Women of child-bearing potential

• Cirrhosis

• Coinfection with HIV or hepatitis B virus