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Hemorrhagic episodes in patients with hemophilia B (Christmas disease) are usually treated with plasma-derived or recombinant factor IX (FIX) concentrates. Because the half-life of FIX is approximately 20 hours, infusions must be given daily to sustain therapeutic levels in bleeding patients and twice weekly to prevent bleeding. Pegylation has been shown to prolong the half-life of various proteins, such as growth hormone and interferon, and now this technology has been used to modify recombinant FIX.
To test the pharmacodynamics and safety of glycopegylated recombinant FIX (N9-GP), investigators from several European hemophilia treatment centers and the drug manufacturer conducted the first human dose trial involving 16 previously treated a…