Hemophilia A

Inclusion Criteria

- Males, age 18 to 65 years.
- Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records

Exclusion Criteria

- Evidence of current or past inhibitor antibody:
- History of any congenital or acquired coagulation disorders other than hemophilia A.
- Platelet count <75,000/mm*3.
- Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.