- Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%)
- Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive
inhibitor test result (above the upper limit of normal) at the local laboratory and
must receive a bypass agent as primary treatment for bleeding episodes.
- Episodic (on-demand) treatment regimen prior to screening
- At least 6 acute bleeding episodes during the 6-month period prior to screening
- Known coronary artery, thrombotic, or ischemic disease
- Concomitant treatment with activated prothrombin complex concentrate