Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection

Inclusion Criteria: * The subject or subject's legally authorized representative has provided written informed consent * The subject has severe hemophilia A as defined by a baseline FVIII activity \<= 1% of normal; tested at screening * The adolescent/adult subject has a documented history of at least 150 exposure days to FVIII concentrates (either plasma-derived or recombinant), and the pediatric subject has at least 50 exposure days * The subject is \>= 12 to \<= 65 years of age for the complete pharmacokinetic assessment and \>= 2 to \< 12 years for the incremental recovery assessment The subject has a Karnofsky performance score \> 60 * The subject is human immunodeficiency virus negative (HIV-) or HIV+ with stable CD4 count \>= 200 cells/mm³ (CD4 count determined at screening, if necessary) Exclusion Criteria: * The subject has a known hypersensitivity to mouse or hamster proteins or to FVIII concentrates * The subject has a history of FVIII inhibitors with titer \>= 0. 5 BU (Bethesda Assay) or \>= 0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening * The subject has a detectable FVIII inhibitor at screening, \>= 0.4 BU (Nijmegen modification of the Bethesda 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 Disease) * The subject has received another investigational product within 30 days of enrollment * The subject's clinical condition may require major or moderate surgery (estimated blood loss \> 500 mL) during the period of participation in the study * Subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance * The subject is a female of childbearing potential with a positive pregnancy test at screening