Safety and efficacy study in subjects with chronic HCV and underlying hemophilia
Phase 1
- Conditions
- Chronic Hepatitis C Virus Infection (Genotype 1b, 2, 3, 4)MedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003463-22-RO
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 71
Inclusion Criteria
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
Exclusion Criteria
or human immunodeficiency virus (HIV)
• Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or
eye disease
• Presence of Bethesda inhibitor
• Current evidence of or history of portal hypertension
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method