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American experience with home use of NovoSeven: recombinant factor VIIa in hemophiliacs with inhibitors.

A novel investigational product, recombinant factor VIIa, manufactured by Novo Nordisk, is presently in clinical trial for evaluation of safety and efficacy when used in the home setting in patients with hemophilia A and B with inhibitors for control of hemostasis in mild to moderate joint, muscle and mucocutaneous bleeding episodes. The clinical trial is an open label, multicenter, uncontrolled study in which 60 patients are enrolled and treated for 1 year with the goal of accumulating 120 evaluable bleeding episodes. Reported here is an outline of the study, review of currently enrolled patient demographics, and the data accumulated to date from the Indiana Hemophilia Comprehensive Center.