DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) reported positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa or rFVIIa treatment for people with hemophilia A or B who develop inhibitors.
The prospective, open-label, randomized, multicenter trial was to assess the safety and efficacy of BAX 817 in male patients aged 12 to 65 with hemophilia A or B, with inhibitors over a 6-month period using on-demand therapy.
The trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, dosing either 3x90 µg/kg or 1x270 µg/kg, with an overall success rate of 92 percent.
Further, 89 percent of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
Full data from the trial, including additional efficacy and safety outcomes, will be presented at a medical meeting in 2015. The company plans to initiate regulatory submissions aligned to manufacturing expansions currently underway.
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