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