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

Trial ID or NCT#

NCT01741545

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
View All Criteria
Show Less

Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

Mindie H. Nguyen, MD
650-498-7878

View on ClinicalTrials.gov