Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

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

Details

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

Criteria

Key Inclusion Criteria:

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

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

• Naïve or nonresponsive to the current standard of care

Key Exclusion Criteria:

• Cirrhosis

• Hepatocellular carcinoma

• Coinfection with hepatitis B virus, HIV-1 or HIV-2