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