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

Status:	Completed
Conditions:	Hepatitis, Hematology
Therapuetic Areas:	Hematology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	3/4/2017
Start Date:	March 2013
End Date:	January 2015

A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

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

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

We found this trial at

sites

Hospital of the University of Pennsylvania

3400 Spruce St
Philadelphia, Pennsylvania 19104

(215) 662-4000