Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors

Inclusion Criteria: * Confirmed diagnosis of congenital haemophilia A or B with inhibitors to FVIII or FIX titer \>5 Bethesda Units \[BU\] * with \> 2 episodes of bleeding/year requiring treatment with FVII infusions, not in bleeding episode * Male adults and adolescents (\>12 years) * Patient informed consent has been obtained \[Patients to be enrolled must also provide voluntary written informed consent to the protocol prior to screening to be eligible for the study. For adolescents, parent/legal guardian must provide consent and, wherever possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent\]. * Patients willing and able to be hospitalized prior to time of study medication administration for plasma sampling (5 times during the study). Exclusion Criteria: * Any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy. * Antibodies against Factor VII * Ongoing bleeding prophylaxis regimens with AryoSeven/NovoSeven or planned to occur during the trial * Platelet count less than 100.000 platelets/mcL (at screening visit) * Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism * HIV positive with current CD4+ count of less than 200/µL * Liver cirrhosis * Factor VIII/IX immune tolerance induction regimen planned to occur during the trial * Known hypersensitivity to the study …