Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b

• HCV RNA viral load ≥10,000 IU/mL

• No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals

• No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year

• Body mass index of 18 to 35 kg/m^2

• Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

• Evidence of decompensated liver disease

• Evidence of medical condition other than HCV contributing to chronic liver disease