Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

• Status: Completed
• Trial end date: 2015-01-31
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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

Inclusion Criteria:

• Severe hemophilia (defined as < 1% factor activity level)

• Infection with the hepatitis C virus (HCV) with underlying hemophilia

• Males 18 years of age and above

• Have not been previously treated with an interferon

Exclusion Criteria:

• Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Chronic liver disease caused by any disease other than chronic HCV infection

• Presence of Bethesda inhibitor

• Current evidence of or history of portal hypertension