Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antiviral Agents; Asunaprevir; HIV Protease Inhibitors; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Protease Inhibitors; Ribavirin

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Chronic Hepatitis C, Genotype 1

• HCV RNA >100,000 IU/mL at screening;

• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);

• Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion Criteria:

• Any evidence of liver disease other than HCV;

• Co-infection with HIV;

• Diagnosed or suspected hepatocellular carcinoma;

• Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin