- Male subjects 18 to inhibitors to FVIII or FIX.
- Subjects is willing and able to comply with the mandatory washout periods prior to
screening and prior to dosing and through 48 hours post dosing. At screening this
includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this
includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72
hours through 48 hours post dosing.
- Subjects must agree and commit to using a a highly effective method of birth control
from the time of screening through four weeks after study drug administration.
- Presence of a bleeding disorder in addition to hemophilia A or B.
- Regular, concomitant therapy with immunomodulating drugs (eg, intravenous
immunoglobulin, and routine systemic corticosteroids).
- History of coronary artery disease, thrombolic disease or diagnosis of prothrombic