The prospective, open-label, randomized, multi-center trial studied the safety and efficacy of BAX 817 in males aged 12–65 with hemophilia A or B with inhibitors for a 6-month period using on-demand therapy. The primary endpoint of successful resolution of acute bleeding episodes at 12 hours was met with both on-demand treatment regimens (3x90mcg/kg or 1x270mcg/kg) at an overall rate of 92%. Also, 89% of patients achieved sustained bleeding control for all acute bleeding episodes 24 hours post-infusion. None of the patients developed inhibitors or binding antibodies to BAX 817, and none discontinued treatment due to an adverse event.
BAX 817 is an investigational recombinant factor VIIa (rFVIIa). Full study data with additional efficacy and safety outcomes will be presented at a medical meeting later in 2015.
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