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Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Not Recruiting
Trial ID: NCT01741545
Purpose
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
Official Title
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
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
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
Intervention(s):
biological: Pegylated-Interferon-lambda
drug: Ribavirin
drug: Daclatasvir
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie H. Nguyen, MD
650-498-7878