BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

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

Summary

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

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

Details

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

Criteria

Inclusion Criteria:

• Participants chronically infected with Hepatitis C virus (HCV) genotype 1

• HCV RNA viral load of ≥10,000 IU/mL at screening

• No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent

• Self-described as Black-African American, Latino or White-Caucasian

• Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.

Compensated cirrhotics were capped at approximately 25%

Exclusion Criteria:

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC)

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