Journal of thrombosis and haemostasis : JTH
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J. Thromb. Haemost. · Mar 2017
Randomized Controlled Trial Multicenter StudySafety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII.
Essentials Recombinant factor VIII BAY 94-9027 conjugates in a site-specific manner with polyethylene glycol. BAY 94-9027 was given to patients with severe hemophilia A as prophylaxis and to treat bleeds. BAY 94-9027 prevented bleeds at dose intervals up to every 7 days and effectively treated bleeds. ⋯ Six hundred and thirty-six of 702 bleeds (90.6%) were controlled with ≤ 2 infusions. No patient developed a FVIII inhibitor. Conclusions BAY 94-9027 prevented bleeding across three individually tailored dose regimens and was effective for treatment of bleeds.