Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

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

Details

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

Criteria

Inclusion Criteria:

• Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4

• HCV RNA viral load of ≥100,000 IU/mL

• No previous exposure to interferon, pegIFNα, or RBV

• Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)

• Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma

• Body mass index of 18 to 35 kg/m^2

Exclusion Criteria:

• Positive for hepatitis B or HIV-1/HIV-2 antibody at screening

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

• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy