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Congenital factor (F)XIII deficiency is a rare hemorrhagic disorder associated with umbilical stump bleeding, postoperative bleeding, recurrent pregnancy losses, and delayed wound healing. Intracranial hemorrhage is also common and often fatal. Prophylaxis is usually recommended for patients with this disorder, but the choices of replacement products are limited.
To evaluate the effectiveness and safety of a new, recombinant FXIII product (rFXIII; Novo Nordisk), industry-supported investigators conducted a multinational, single-arm, phase III, prophylaxis trial involving 41 patients with congenital FXIII-A subunit deficiency. Patients received 35 IU/kg of rFXIII intravenously every 4 weeks for 52 weeks; average FXIII activity trough levels >…