A Randomized Two-way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII BDDrFVIII, ReFacto AF With a Full-Length Recombinant Factor VIII Preparation FLrFVIII, Advate , Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A
- Conditions
- HAEMORRAGIES PREVENTION AND CONTROL IN COAGULATION FACTOR VIII - DEFICIT PATIENTS DUE TO HAEMOPHILIA A
- Registration Number
- EUCTR2005-000720-16-IT
- Lead Sponsor
- WYETH LEDERLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method