Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A

Mahlangu, Johnny; S. Powell, Jerry; V. Ragni, Margaret; Chowdary, Pratima; C. Josephson, Neil; Pabinger, Ingrid; Hanabusa, Hideji; Gupta, Naresh; Kulkarni, Roshni; Fogarty, Patrick; J. Perry, David; D. Shapiro, Amy; Pasi, John; Apte, Shashikant; Nestorov, Ivan; Jiang, Haiyan; Li, Shuanglian; Neelakantan, Srividya; M. Cristiano, Lynda; Goyal, Jaya; M. Sommer, Jürg; Dumont, Jennifer; Dodd, Nigel; Nugent, Karen; Vigliani, Gloria; Luk, Alvin; M. Brennan, Aoife; F. Pierce, Glenn

doi:10.1182/blood-2013-10-529974

Public

Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A

Published in Blood • Nov 14, 2013

Authors:

Johnny Mahlangu

Jerry S. Powell

Margaret V. Ragni

Abstract

This phase 3 pivotal study evaluated the safety, efficacy, and pharmacokinetics of a recombinant FVIII Fc fusion protein (rFVIIIFc) for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control in 165 previously treated males aged ≥12 years with severe hemophilia A. The study ha...

Subject

Medicine

Adverse effect

Pharmacokinetics

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