rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

Inclusion Criteria: * Patients with hemophilia A who have been treated with factor VIII on demand or on prophylaxis and who have developed inhibitors to factor VIII * ≤ 2 years from the time of first inhibitor detection. * High-responding inhibitors (historical peak \> 5 BU/mL)and known anamnestic response in case of negative inhibitor titre. * Candidates to start daily ITI with FVIII doses ranging from 50 IU/Kg/day to 200 IU/Kg/day * Maximal two bleedings in the same joint within the last 6 months before entering the study or maximal six joint bleeds in the same joint within 2 years * Adequate venous access for daily infusion and capable (caregiver) of reconstituting and injecting the study drug * Informed consent by parents or legal guardians. Exclusion Criteria: * ITI already started * Known or suspected hypersensitivity to the active substance or to any of the excipients of the study drug * Administration of any investigational product within 30 days prior to randomisation * Other coagulation disorders than congenital hemophilia A. * Family history of thrombosis at an early age (\< 40 years), known thrombophilia, any previous thrombosis including catheter-related deep vein thrombosis, previous neonatal thrombosis. * Known pseudo tumours * Known severe liver disease * Platelet count \< 50,000 platelets/µL at screening * Surgery within one month or planned major and/or orthopaedic surgery.