Using reagents specific to Japan to measure turoctocog alfa pegol in hemophilia A plasma: A two-site study
Author:
Affiliation:
1. Novo Nordisk Pharma, Tokyo, Japan
2. Novo Nordisk A/S, Måløv, Denmark
Publisher
Japanese Society on Thrombosis and Hemostasis
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjsth/31/3/31_2020_JJTH_31_3_334-339/_pdf
Reference16 articles.
1. 1) Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D: Enhancing the pharmacokinetic properties of recombinant factor VIII: First-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost 11: 670–678, 2013.
2. 2) Meunier S, Alamelu J, Ehrenforth S, Hanabusa H, Abdul Karim F, Kavakli K, Khodaie M, Staber J, Stasyshyn O, Yee DL, Rageliene L: Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A. Thromb Haemost 117: 1705–1713, 2017.
3. 3) Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jonsson PG, Oldenburg J: Pathfinder I: Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost 117: 252–261, 2017.
4. 4) Hampton K, Chowdary P, Dunkley S, Ehrenforth S, Jacobsen L, Neff A, Santagostino E, Sathar J, Takedani H, Takemoto CM, Negrier C: First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A. Haemophilia 23: 689–696, 2017.
5. 5) Curry N, Albayrak C, Escobar M, Andre Holme P, Kearney S, Klamroth R, Misgav M, Negrier C, Wheeler A, Santagostino E, Shima M, Landorph A, Tonder SM, Lentz SR: Once-weekly prophylaxis with glycoPEGylated recombinant factor VIII (N8-GP) in severe haemophilia A: Safety and efficacy results from pathfinder 2 (randomized phase III trial). Haemophilia 25: 373–381, 2019.
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