Phase I study of BAY 94‐9027, a PEGylated B‐domain‐deleted recombinant factor VIII with an extended half‐life, in subjects with hemophilia A

Abstract

This phase I study demonstrates that BAY 94-9027 has an extended half-life in subjects with hemophilia A and, after multiple dosing, was well tolerated with no immunogenicity during the 8-week trial. A phase III study in a larger number of subjects is underway to fully characterize how this prolonged half-life will permit less frequent prophylaxis dosing for patients with hemophilia.