1. Greater than or equal to (> or =) 18 to less than or equal to (< or =) 65 years old at
the time of screening.
2. Hemophilia A or B of any severity, with a documented > or = 3 months history of
inhibitors (> or = 0.6 Bethesda units [BU]) requiring the use of bypassing agents
(FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if
no documented history is available.
3. Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain
reaction (PCR); or HCV positive with stable liver disease.
4. Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and
CD4 count > or = 200 cells per cubic millimetre (cell/mm3) at screening.
5. Adequate venous access.
6. Willing and able to comply with the requirements of the protocol.
7. If a female of childbearing potential, must have a negative blood pregnancy test and
agrees to employ adequate birth control measures for the duration of the study, such
as: a. Abstain from sexual intercourse, b. Use a reliable method of contraception
(contraception such as an intrauterine device, barrier method [e.g., diaphragm or
sponge; female condom not permitted] with spermicide, oral contraceptive, injectable
progesterone, sub dermal implant), and have their male partner use a condom
8. If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the
1. Postmenopausal, defined as amenorrhea for at least 12 months following cessation
of all exogenous hormonal treatments and with follicle-stimulating hormone levels
within the laboratory-defined postmenopausal range or postmenopausal with
amenorrhea for at least 24 months and on hormonal replacement therapy.
2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral
oophorectomy, bilateral tubal ligation (with no subsequent pregnancy at least 1
year from bilateral tubal ligation), or bilateral salpingectomy.
1. Known hypersensitivity to FEIBA or any of its components.
2. Advanced liver disease (e.g., liver biopsy confirmed diagnosis of cirrhosis, portal
vein hypertension, ascites, prothrombin time [PT] 5 seconds above upper limit of
3. Planned elective surgery during participation in this study (excluding minor
procedures that will not need preventative bleeding treatments, such as exchanges of
peripherally inserted central catheters).
4. Platelet count less than (<) 100,000/ microliter (μL).
5. Taking Emicizumab (Hemlibra) for bleed prevention.
6. Clinical or laboratory evidence of disseminated intravascular coagulation based on
7. Prior history or evidence of thromboembolic event: acute myocardial infarction, deep
vein thrombosis, pulmonary embolism, etc.
8. Diagnosis of advanced atherosclerosis, malignancy, and/or other diseases that may
increase the participant's risk of thromboembolic complications.
9. Participant is taking any immunomodulating drug (e.g., corticosteroid agents at a dose
equivalent to hydrocortisone greater than (>) 10 milligram per day (mg/day), or
α-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy.
10. Herbal supplements that contain anti-platelet activity.
11. Participant has participated in another clinical study involving an investigational
product (IP) or investigational device within 30 days prior to enrollment or is
scheduled to participate in another clinical study involving an IP or investigational
device during the course of this study.
12. Participant is a family member or employee of the investigator.
13. 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.