Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery

This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.

Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study: 1. be male with a diagnosis of congenital hemophilia A or B of any severity 2. have one of the following: 1. current positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) or history of high-responding inhibitors (BU ≥5) not further successfully treated by Immune Tolerance Induction OR 2. a condition precluding the use of FVIII or FIX products to treat or prevent bleeding such as a previous anamnestic response after exposure to factor concentrates or a previous failure to respond to FVIII or FIX concentrates 3. be ≥12 years to ≤65 years of age on the day of informed consent 4. be scheduled for an elective major surgical procedure as defined in the study protocol (see Table ''Definitions for the specific purpose of Study F7TG2202'') 5. have Hb ≥ 12 g/dL 6. be capable of understanding and willing to comply with the conditions of the protocol OR in the case of a patient under the age of legal majority, parent(s)/legal guardian(s) must be capable of understanding and willing to comply with the conditions of the protocol 7. have read, understood, and provided written informed consent (patient or parent(s)/legal guardian(s) if the patient is minor according to local regulation) and, where applicable according to local regulation, patient's assent if the patient is minor Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. 1. have any coagulation disorder other than hemophilia A or B 2. be immunosuppressed (i.e. the patient should not be receiving systemic immunosuppressive medication; CD4+ cell counts at screening should be \>200/μL) 3. known intolerance to EB or any of its excipients 4. currently receiving immune tolerance induction (ITI) therapy 5. have a known or suspected allergy or hypersensitivity to rabbits or rabbit proteins 6. have platelet count \