A prospective, observational, post-approval registry of inhibitor patients treated with multiple or single doses of recombinant activated factor VII.

In March 2007, the European Medicines Agency (EMEA) approved the use of single-dose recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark) 270 microg/kg for the treatment of mild-to-moderate bleeding episodes in patients with hemophilia A or B with inhibitors. The prospective, observational ONE Registry was recently established to describe "real world" use of the standard multiple-dose (3 x 90 microg/kg) and new single-dose (270 microg/kg) regimens, and to compare their safety, effectiveness, and effects on both quality of life and patient satisfaction with treatment. Enrollment started at the beginning of 2008, with a planned recruitment period of 18 months, and it is expected that approximately 100 patients will be enrolled from up to 30 European hemophilia centers.