A single dose, randomized, 2-period crossover study in patients with hemophilia A to evaluate the pharmacokinetics of ReFactoO' [B-domain deleted recombinant human factor VIII (BDDrFVIII)] and AdvateO' [a full-length recombinant factor VIII (FLrFVIII)]
- Conditions
- Prevention and treatment of bleedings in patients with haemophilia AMedDRA version: 14.1Level: PTClassification code 10056493Term: Haemophilia A without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2004-003727-12-IT
- Lead Sponsor
- WYETH LEDERLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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) no
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