Conditions: Hemophilia A
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 9
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Detailed description:

Arms:
arm 1: Advate rAHF-PFM arm 2: Recombinate rAHF

Interventions: intervention 1: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) intervention 2: Recombinant Factor VIII (rAHF)
Intervention descriptions: intervention 1: Infusion of 50 +/- 5 IU/kg bodyweight intervention 2: Infusion of 50 +/- 5 IU/kg bodyweight

Protocol document: