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In patients with severe hemophilia B, infusing factor IX concentrates twice a week can prevent spontaneous bleeding. However, infusions must be given intravenously, and venous access is often problematic. Reducing the frequency of infusions by prolonging the half-life of the clotting factor would simplify treatment.
To address the safety and efficacy of a long-acting construct of recombinant factor IX and the Fc domain of immunoglobulin G1 (rFIXFc), investigators conducted a manufacturer-sponsored, phase III, nonrandomized trial involving 123 males (age, ≥12) with severe hemophilia B. Pharmacokinetic data from 22 patients showed that the half-life of rFIXFc was significantly longer than that of rFIX (82.1 vs. 33.8 hours; P<0.001), as was the…