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

• Published in: Journal of thrombosis and haemostasis Vol. 12; no. 4; pp. 488 - 496
• Main Authors: Coyle, T. E., Reding, M. T., Lin, J. C., Michaels, L. A., Shah, A., Powell, J.
• Format: Journal Article
• Language: English
• Published: England Elsevier Limited 01.04.2014; Blackwell Publishing Ltd
• Subjects: Adult; Animals; Clinical Haemostasis and Thrombosis; clinical trial, Phase 1; Factor VIII - chemistry; Factor VIII - pharmacokinetics; factor VIII; Hemophilia; Hemophilia A - blood; Hemophilia A - drug therapy; hemophilia A; Humans; Male; Middle Aged; Peptide Fragments - chemistry; Peptide Fragments - pharmacokinetics; pharmacokinetics; Polyethylene Glycols - chemistry; Polyethylene Glycols - pharmacokinetics; Prospective Studies; recombinant proteins; Recombinant Proteins - chemistry; Recombinant Proteins - pharmacokinetics; Treatment Outcome; Young Adult

Summary Background BAY 94‐9027 is a B‐domain‐deleted recombinant factor VIII (rFVIII) with site‐specific attachment of poly(ethylene glycol) that has shown an extended half‐life in animal models of hemophilia. Objectives To assess the pharmacokinetics and safety of BAY 94‐9027 after single and repea...