Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1

• Non-responder to prior therapy with peginterferon alfa and ribavirin

• HCV RNA viral load of 100,00 IU/mL

• Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)

• Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma

• Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

• Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening

• Evidence of medical condition associated with chronic liver disease other than HCV

• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy