A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

• Status: Withdrawn
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.

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

Details

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

Criteria

Inclusion Criteria:

• Treatment-naive subjects with genotype 1 chronic HCV

• HCV RNA ≥ 100,000 IU/mL at screening

• Seronegative for HIV and HBsAg

• Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion Criteria:

• Any evidence of liver disease other than hepatitis C

• Diagnosed or suspected hepatocellular carcinoma

• Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men

• Cirrhosis