Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A

Inclusion Criteria: Subject is less than 6 years of age Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level <= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis) Documented medical history of at least 50 exposure days for treatment with all other factor VIII products Subject's parent or legally authorized representative has provided informed consent Exclusion Criteria: Detectable inhibitor to factor VIII measured in the screening sample by the local or central hemostasis laboratory History of inhibitor to factor VIII at any time prior to screening Subject has any one of the following laboratory abnormalities at the time of screening: platelet count < 100,000/mm3 hemoglobin concentration < 10 g/dL (100 g/L) serum creatinine > 1.5 times the ULN for age total bilirubin > 2 times the ULN for age Subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., platelet dysfunction secondary to uremia, liver failure, von Willebrand's Disease) Subject has known hypersensitivity to RECOMBINATE rAHF Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures