- Male subjects less than 12 years of age with a documented history of severe
hemophilia A (FVIII:C less than 1%).
- Subjects who are less than 6 years of age must have had at least 50 Exposure Days
(EDs) to prior FVIII products (including blood products).
- Subjects who are equal to or greater than 6 years of age must have had greater than
150 EDs to prior FVIII products (including blood products).
- For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
titer greater than ULN for the testing laboratory at the time of screening.
- Any other bleeding disorder in addition to hemophilia A.
- Treatment with any investigational drug or device within 30 days before the time of
signing the parental informed consent/assent form.
- Major surgery planned to occur during the course of the study.
- Regular (e.g., daily; every other day) use of agents or medications known to
influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory
- Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
immune tolerance induction (ITI) for inhibitor treatment.
- The subject is receiving treatment for HIV or hepatitis infection (unless the subject
is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
months before the parental informed consent/assent form is signed]).
- Platelet count less than 100,000/µL.
- Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international
normalized ratio (INR) equal to or greater than 1.5.
- Known hypersensitivity to hamster protein.