Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Timothy Morgan, MD
• Collaborators: Bristol-Myers Squibb; National Cancer Institute (NCI); VA Long Beach Healthcare System
• Treatments: Asunaprevir; Ribavirin

Criteria

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1a

• HCV RNA ≥ 10,000 IU/mL at screening

• Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion Criteria:

• Evidence of cirrhosis

• Liver or any other organ transplant

• Current or known history of cancer within 5 years prior to enrollment

• Documented or suspected hepatocellular carcinoma (HCC)

• Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy