- Male patients less than 6 years of age with moderately severe to severe hemophilia A
(FVIII less than or equal to 2%).
- Treatment history of less than 50 exposure days to prior recombinant or plasma-derived
FVIII replacement products.
- Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable
antiviral regimen at the time of enrollment in the study.
- Presence of any bleeding disorder in addition to hemophilia A.
- Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening.
- Treated with immunomodulatory therapy during the screening period
- Treatment history of more than 5 exposure days (ED) to Xyntha.
- Known hypersensitivity to hamster protein.