A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject.

The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir; Ribavirin

Criteria

Inclusion Criteria:

• Chronic HCV-1b infected patient

• HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening

• Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)

• Treatment naive subjects to Interferon (IFN) based therapy

• Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

Exclusion Criteria:

• Patients who have;

• Hepatocellular carcinoma

• Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)

• Severe or uncontrollable complication