- Male patients 12 years of age and older.
- Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII
replacement products.
- Treatment history of 150 or greater exposure days to any FVIII products prior to
Enrollment visit.
- Negative inhibitor at screening or documentation of negative inhibitor titer within 6
weeks or less prior to study entry except for patients entering the study on immune
tolerance induction therapy.
- Bleeding disorder other than hemophilia A.
- Inhibitor titer greater than or equal to 0.6 BU during screening except for patients
on immune tolerance induction therapy.
- Immunomodulatory therapy during screening period.
- Known hypersensitivity to hamster protein.