A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A
1. To determine the safety of BAX 855 based on incidence of neutralizing inhibitor development. 2. To determine the efficacy of BAX 855 based on ABR as determined by development of spontaneous bleeds (bleeds not associated with trauma).
Keywordsinhibitor, BAX855, bleeds, neutralizing, trauma
Principal InvestigatorTung Wynn, M.D.
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