Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor

Inclusion Criteria:

- Signed and dated informed consent form by the participant or the participant's legally
authorized representative

- The participant is ≥ 4 to ≤ 65 years of age

- The participant has a Karnofsky performance score of ≥ 60

- Hemophilia A and B of any severity, with documented history of high-titer inhibitor (>
5 Bethesda unit (BU)) for at least 12 months; or, if inhibitor titer is ≤ 5 BU, and
the participant is refractory with increased dosing of either factor VIII (FVIII) or
factor IX (FIX), as demonstrated from the participant's medical history

- Currently being treated on an on-demand basis for treatment of bleeding episodes

- Adequate venous access, with or without central venous device

- ≥ 12 bleeding episodes requiring treatment with by-passing agents in the past 12
months, based on medical history

- Competent in-home treatment and infusion therapy

- Currently using bypassing agents (activated prothrombin complex concentrate (APCC) or
recombinant activated factor VII (rFVIIa)) for treatment of bleeding episodes

- HCV-, either by antibody testing or polymerase chain reaction (PCR); or HCV+ with
stable hepatic disease

- HIV-, or HIV+ with stable disease and CD4 count > 200 cells/mm3 at screening

- Female participant of childbearing potential, presents with a negative serum pregnancy
test, and agrees to employ adequate birth control measures for the duration of the
study

Exclusion Criteria:

- Currently receiving immune tolerance induction (ITI)

- Currently on regular prophylactic therapy to prevent bleeding episodes

- Clinically symptomatic liver disease (e.g. diagnosis of cirrhosis [confirmed by liver
biopsy], portal vein hypertension, ascites, prothrombin time (PT) 5 seconds above
upper limit of normal)

- Platelet count < 100,000/ml

- Planned elective surgery during participation in this study

- Participant is currently participating in another clinical study and has received an
investigational product or device within 30 days prior to study entry

- Planned use of pegylated or non-pegylated alpha-interferon with or without ribavirin
for HCV infected participants or planned use of a protease inhibitor for HIV infected
participants. Participants currently taking any of these medications for a 30-day
course are eligible.

- Clinically significant increase in D-dimer levels from historical baseline and/or
associated with chronic liver disease or clinically evident thromboembolic event

- Known hypersensitivity to anti-inhibitor coagulant complexes (AICCs)

- Currently treated with a systemic immunomodulating drug

- Prior history of thromboembolic event: acute myocardial infarction, deep vein
thrombosis, or pulmonary embolism

- Diagnosis of advanced atherosclerosis, malignancy and/or other diseases that may
increase the participant's risk of thromboembolic complications

- Clinically significant medical, psychiatric, or cognitive illness, or recreational
drug/alcohol use that, in the opinion of the investigator, would affect participant
safety or compliance