This information will be used to develop strategies to prevent these complications. This study is intended to evaluate the efficacy of immune tolerance induction using a short course of factor VIII combined with vincristine and prednisone in high risk pediatric hemophilia A patients with high titer inhibitors Study design. Following induction, patients will continue on daily factor VIII until CR is achieved. Then prophylaxis factor VIII will be given 3 times per week. This is an open-label, randomized, US and Canadian trial comparing the safety and efficacy of continuous infusion of rFVIIa to bolus injection in patients undergoing an elective surgical procedure.
Patients undergoing pre-planned major surgery are eligible for enrollment.
Upon qualification for enrollment, patients will be randomly assigned to either the bolus or infusion group. This is a Phase III open-label replacement therapy study.