An Exploratory Study to Evaluate the Dose Response Relationship of Pharmacodynamic Parameters of Aryoseven in Patients with Hemophilia A and B 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, non in bleeding episode Male adult and adolescents (>12 years) Patients 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 medication Parallel participation in another experimental drug trial. Parallel participation in another marketed drug trial that may affect the primary end point of the study. Concomitant diseases and/or medications, or any other conditions, that render the patient unsuitable for inclusion into the study in the judgment of the investigator.

Target sample size: 12