Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

Inclusion Criteria: * Have haemophilia A or B with inhibitors to factor VIII or IX, respectively * Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA * Require pre-planned major surgery in hospital Exclusion Criteria: * Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days * Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose * Have any haemostatic disorder other than haemophilia