Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

Inclusion Criteria:

- The subject has severe or moderately severe hemophilia A as defined by a baseline
factor VIII level <= 2% of normal, as tested at screening

- The subject has a documented history of at least 150 exposure days to factor VIII
concentrates (either plasma-derived or recombinant)

- The subject is within 7 to 65 years of age

- The subject has a Karnofsky performance score > (greater than) 60

- The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a CD4
count >= 400 cells/mm³ (CD4 count determined at screening, if necessary)

- The subject has been on a documented on-demand treatment regimen for at least 12
months immediately prior to enrollment

- The subject has a documented history (e.g. in medical charts or dispensing
information, or signed investigator statement) of at least 8 joint hemorrhages in the
12 months immediately prior to enrollment

- The subject resides within the coverage area of the mobile compliance device; coverage
area will be determined at screening

- The subject or the subject's legally authorized representative has provided written
informed consent

Exclusion Criteria:

- The subject has a known hypersensitivity to factor VIII concentrates or mouse or
hamster proteins

- The subject has a history of factor VIII inhibitors with a titer >= 0.6 BU (by
Bethesda or Nijmegen assay) at any time prior to screening

- The subject has a detectable factor VIII inhibitor at screening, with a titer >= 0.4
BU (by Nijmegen Assay) in the central laboratory

- The subject has severe chronic liver disease as evidenced by, but not limited to, any
of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal
vein hypertension including presence of otherwise unexplained splenomegaly and history
of esophageal varices.

- The subject has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (e.g., qualitative platelet defect or von Willebrand's Disease)

- The subject has been treated during the last sixty (60) days prior to or is being
treated at screening/enrollment with an immunomodulating drug.

- The subject has participated in another investigational study within thirty (30) days
of enrollment

- The subject has previously participated in a clinical study with rAHF-PFM

- The subject's clinical condition may require a major surgery (defined as moderate to
critical risk and perioperative blood loss ≥ 500 mL) during the period of the
subject's participation in the study

- The subject is female of childbearing potential with a positive pregnancy test