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

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

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