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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

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

Details

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

Criteria

Key Inclusion Criteria:

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

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

• The current standard of care naïve or non-responder

Key Exclusion Criteria:

• Cirrhosis

• HCC

• Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2