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.

@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 Mamonov and Luminita Rusen and Jos{\'e} Luis Lamas and M S Oh and Mark S Chapman and Sandor Fritsch and Borislava G. Pavlova and Wai-Yeung Wong and Brigitt E Abbuehl},
  journal={Haemophilia : the official journal of the World Federation of Hemophilia},
  year={2014},
  volume={20 1},
  pages={15-24}
}
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 treated patients aged 12-65 years with severe or moderately severe haemophilia B. BAX326 was safe and well tolerated in all 73 treated… CONTINUE READING

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