An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the Efficacy, Safety, and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (Moroctocog alfa [AF-CC]) in Children With Hemophilia A - ND
- Conditions
- Hemophilia AMedDRA version: 12.0Level: LLTClassification code 10056493Term: Haemophilia A without inhibitors
- Registration Number
- EUCTR2006-005575-17-IT
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
Males < 6 years of age with moderately severe to severe hemophilia A (FVIII activity >= 2%), with previous FVIII replacement therapy experience ( 50 exposure days).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Current or history of FVIII inhibitor.
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