None listed
Conditions
Interventions
Intervention1: Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA.: Dosage form: kit
powder, lyophilized, for solution/suspension
injection
Dosage frequency: IP will be infused every 48hours (-8 hours/+24 hours).
Mode of Administration: intravenous
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Baxalta Innovations GmbH
Baxalta Bioscience India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. � 18 to � 65 years old at the time of screening 2. Hemophilia A or B of any severity, with a documented � 3 months history of inhibitors (� 0.6 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 � 200 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: a. 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 b. 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
Exclusion criteria: Inclusion criteria Subject is/has: 1. ââ?°Â¥ 18 to ââ?°Â¤ 65 years old at the time of screening 2. Hemophilia A or B of any severity, with a documented ââ?°Â¥ 3 months history of inhibitors (ââ?°Â¥ 0.6 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 ââ?°Â¥ 200 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: a. 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 b. 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: Subject is/has: 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 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 subjectââ?¬•s risk of thromboembolic complications 9. Taking any immunomodulating drug (e.g., corticosteroid agents at a dose equivalent to hydrocortisone > 10 mg/day, or Ã?±-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy. 10. Herbal supplements that contain anti-platelet activity 11. Participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate tolerability and safety of FEIBA reconstituted in a 50% reduced volume of sterile water for injection (SWFI) administered at the standard infusion rate of 2U/kg/min and at increased rates of 4 and 10 U/kg/min, based on the occurrence of any adverse event, in particular of thromboembolic events and hypersensitivity reactions. Timepoint: To evaluate tolerability and safety of FEIBA reconstituted in a 50% reduced volume of sterile water for injection (SWFI) administered at the standard infusion rate of 2U/kg/min and at increased rates of 4 and 10 U/kg/min, based on the occurrence of any adverse event, in particular of thromboembolic events and hypersensitivity reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to monitor pre (within 60 min before the infusion) and post-infusion (at 30 min, hours 1, 2, 6, 8 and 12) activity of coagulation factor II The secondary objective is to evaluate subject treatment preference using Treatment Satisfaction Questionnaire for Medication (TSQM) and patient preference questionnaireTimepoint: Time period: within 60 min before the infusion and post-infusion at 30 min, hours 1, 2, 6, 8 and 12. Time period: Throughout the study period. | — |
Countries
Algeria, Croatia, India, Malaysia, Poland, Romania, Serbia, South Africa, Thailand, The former Yugoslav Republic of Macedonia, Turkey, Ukraine
Contacts
Public ContactGopal Agrawal
Baxalta Bioscience India Pvt. Ltd
Outcome results
None listed