FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
Condition: Hemophilia A or B With Inhibitors
MeSH terms: Hemophilia A
Intervention: FEIBA
Intervention description: Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Intervention MeSH terms: Thrombin; Anti-inhibitor coagulant complex; Coagulants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to:

        -  1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight
           Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min

        -  2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased
           rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the
           regular volume
    

Eligibility criteria:

        Inclusion Criteria:

          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
             following criteria:

               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.

        Exclusion criteria:

          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
             normal).

          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
             medical history.

          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.