Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Pharmasset
• Treatments: Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Men and women, ages 18 to 70 years.

• Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).

• Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by:

positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

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

• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.

• History of hemophilia.

• History of torsade de pointes.

• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.

• History of gastrointestinal disease or surgical procedure (except cholecystectomy).

• History of clinically significant cardiac disease.

• Blood transfusion within 4 weeks prior to study drug administration.

• Poor venous access.

• Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.