BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

Inclusion Criteria: * Males aged 12 to 70 years * Subjects with severe hemophilia A (\< 1% factor VIII \[FVIII\]:C) * Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total * Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule * Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records * Subjects with no measurable inhibitor activity * Subjects with no history of FVIII inhibitor antibody formation * Written informed consent by subject and parent / legal representative, if \< 18 years Exclusion Criteria: * Subjects who are receiving primary prophylaxis * Subjects on prophylaxis with documented requirements of \> 75 IU/kg/week * Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease) * Subjects with abnormal renal function * Subjects with elevated hepatic transaminases * Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study * Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG) * Subjects who require any pre-medication for FVIII injections