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: 1. platelet count \< 100,000/mm3 2. hemoglobin concentration \< 10 g/dL (100 g/L) 3. serum creatinine \> 1.5 times the ULN for age 4. 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