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

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antiviral Agents; Interferons; Ribavirin

Criteria

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