- Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
- Previously treated patients with greater than or equal to 250 exposure days to any
Factor VIII product
- Age greater than or equal to 12 years
- History of prophylaxis dosing at least twice per week on any Factor VIII product for
at least 3 consecutive months within the 2 years prior to study enrollment unless the
patient completed the previous pharmacokinetic study
- Adequate laboratory results
- Presence of any bleeding disorder in addition to hemophilia A
- Concomitant therapy with immunosuppressive drugs
- Current or historical Factor VIII inhibitor
- Treatment with any investigational drug or device within the past 30 days