Lead Sponsor

Bayer

Age

12 - 60 years

Sex

MALE

Healthy Volunteers

No

•Subjects with severe hemophilia A (\< 2% FVIII:C)
•Subjects with no history of FVIII inhibitor antibody formation
•Subjects with no measurable inhibitor activity
•Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
•Subjects whose current treatment with any CHO rFVIII product
•Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
•Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency

•Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
•Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
•Any individual with a past history of severe reaction(s) to FVIII concentrates
•Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
•Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
•Subjects who require any medication for FVIII infusions

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