Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level <1%) or moderately severe (FIX level ≤2%) haemophilia B.

Abstract

BAX326 is a recombinant factor IX (rFIX; nonacog gamma) manufactured without the addition of any materials of human or animal origin, and with two viral inactivation steps (solvent/detergent treatment and 15 nm nanofiltration). The aim of this prospective trial was to investigate the pharmacokinetics, haemostatic efficacy and safety of BAX326 in previously… (More)
DOI: 10.1111/hae.12228

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@article{Windyga2014PharmacokineticsEA, title={Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level <1%) or moderately severe (FIX level ≤2%) haemophilia B.}, author={J Windyga and Toshko J. Lissitchkov and Oleksandra Stasyshyn and Vasily E Mamonov and Luminita Rusen and Jos{\'e} Luis Lamas and M-S Oh and Matthew R Chapman and Sandor Fritsch and Borislava G. Pavlova and W. T. Wong and Brigitt E Abbuehl}, journal={Haemophilia : the official journal of the World Federation of Hemophilia}, year={2014}, volume={20 1}, pages={15-24} }