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…