A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients From ≥6 Months Old to <12 Years Old With Inhibitors to Factor VIII or IX

Inclusion Criteria:

- be male with a diagnosis of congenital hemophilia A or B of any severity

- have one of the following:

- a positive inhibitor test BU ≥5, OR

- a Bethesda Unit (BU) <5 but expected to have a high anamnestic response to FVIII or
FIX, as demonstrated from the patient's medical history, precluding the use of factor
VIII or IX products to treat bleeding episodes, OR

- a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as
demonstrated from the patient's medical history, precluding the use of factor VIII or
IX products to treat bleeding episodes

- be ≥6 months old, but <12 years old

- have experienced at least 3 bleeding episodes of any severity in the past 6 months

- parents or legal guardians must be capable of understanding and be willing to comply
with the conditions of the protocol

- parents or legal guardians must have read, understood, and provided written informed
consent

Exclusion Criteria:

- have any coagulation disorder other than hemophilia A or B

- be immunosuppressed (i.e., the patient may not be receiving systemic
immunosuppressive medication; cluster of differentiation 4 (CD4) counts at screening
must be >200/µL)

- have a known allergy or hypersensitivity to rabbits

- have platelet count <100,000/mL

- have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior
to first administration of study drug

- have received an investigational drug within 30 days of first study drug
administration, or be expected to receive such drug during participation in this
study