Overview

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