Health Condition 1: null- Male patients with Hemophilia A or B with FVIII or FIX Inhibitors
Conditions
Interventions
Intervention1: rFVIIa BI: Arm 1
45µg/kg
Recruitment for Arm 1 is closed. India will only participating for Arm 4 recruitment.
Intervention2: rFVIIa BI: Arm 2
90µg/kg
Recruitment for Arm 2 is closed. India will only participating for Arm 4 recruitment.
Intervention3: rFVIIa BI: Arm 3
180µg/kg
Recruitment for Arm 3 is closed. India will only participating for Arm 4 recruitment.
Intervention4: rFVIIa BI: Arm 4
279µg/kg Subjects will received a single infusion. Study duration is 3-6 weeks from enrollment to study completion.
Control Intervention1: NovoSeven: Arm 2
90µg/kg
Recruitment for Arm 2 is closed. India will only participating for Arm 4 recruitment.
Control Intervention2: Comparator NovoSeven: Arm 2
90µg/kg
Recruitment for Arm 2 is closed. India will only participating for Arm 4 recruitment.
Sponsors
Baxter Innovations GmbH
Eligibility
Inclusion criteria
Inclusion criteria: ? Male Hemophilia A or B with inhibitors at ≥ 0.6 Bethesda Units ? Age from 18 to 65 years at the time of screening ? Karnofsky Performance Score ≥ 60 ? Hepatitis C virus negative (HCV-) by antibody testing or PCR; or HCV+ with stable hepatic disease ? Human Immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥200 cells/mm3 at screening ? Subject is willing and able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: ? Concomitant Immune Tolerance Induction ? Currently on regular prophylaxis therapy to prevent bleeding episodes ? Positive for FVII inhibitor ? Clinically symptomatic liver disease (eg, diagnosis of cirrhosis, [liver biopsy confirmed], portal vein hypertension, ascites, prothrombin time ≥ 5 seconds above upper limit of normal) ? Platelet count 100,000/μl ? Planned use of α-interferon with or without ribavirin for HCV-infected patients or planned use of a protease inhibitor for HIV-infected patients. Patients currently taking any of these medications for ≥ 30 days are eligible ? D-dimer levels ≥ 2 time the upper level of normal ? Known hypersensitivity to rFVIIa or hamster or murine proteins ? Prior history of thromboembolic event (eg, acute myocardial infarction, deep vein thrombosis, pulmonary embolism) ? Prior diagnosis of atherosclerosis, malignancy and/or other diseases that may increase the subject?s risk of thromboembolic complications ? Subject has participated in another clinical study involving an 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PharmacokineticTimepoint: Screening visit, Pre-Infusion, Post-Infusion, 12h Post- Infusion, 2wk + 2d | — |
Secondary
| Measure | Time frame |
|---|---|
| ExploratoryTimepoint: Screening visit, Pre- Infusion, Post-Infusion, 12h Post- Infusion, 2wk + 2d;Immediate TolerabilityTimepoint: Screening visit, Pre- Infusion, Post-Infusion, 12h Post- Infusion, 2wk + 2d;PK parameters Timepoint: Screening visit, Pre- Infusion, Post-Infusion, 12h Post- Infusion, 2wk + 2d ;SafetyTimepoint: Screening visit, Pre- Infusion, Post-Infusion, 12h Post- Infusion, 2wk + 2d | — |
Countries
Brazil, France, Germany, India, Japan, Mexico, Poland, Romania, Russian Federation, Ukraine, United States of America
Contacts
Public ContactDr Ashok Moharana
Outcome results
None listed