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

Completed · Phase 3

Conditions studied: Hepatitis C Virus

In brief

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

Key facts

Study ID

NCT01741545

Run by

Bristol-Myers Squibb

People needed

71

Starts

2013-03-31

Expected to finish

2015-01-31

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Boswell Clinic — Palo Alto, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Hospital Of The University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Clinical Research Centers Of America — Murray, Utah, United States
• Local Institution — Camperdown, New South Wales, Australia
• Local Institution — Herston, Queensland, Australia
• Local Institution — Adelaide, South Australia, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution — Herston, Australia
• Local Institution — Grenoble, France
• Local Institution — Lyon, France
• Local Institution — Montpellier, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Vandœuvre-lès-Nancy, France
• Local Institution — Florence, Italy
• Local Institution — Milan, Italy
• Local Institution — Roma, Italy
• Local Institution — Torino, Italy
• Local Institution — Amsterdam, Netherlands
• Local Institution — Nijmegen, Netherlands
• Local Institution — Rotterdam, Netherlands
• Local Institution — Utrecht, Netherlands
• Local Institution — Bucharest, Romania
• Local Institution — Constanța, Romania

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.