Mim8 Clinical Development Program: An Overview of the Frontier Studies

Autor: Stephanie Valer Seremetis, Wan Hui Ong Clausen, Irina Matytsina, Susanne Møller Nissen, Karin Wåhlander

Publikováno v: Blood. 140:5630-5631

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::764f10c6afbe0c9bc7aa20eacf6bda31
https://doi.org/10.1182/blood-2022-163554

A field study evaluating the activity of N8‐GP in spiked plasma samples at clinical haemostasis laboratories

Autor: Mirella Ezban, Martin Hansen, Rasmus Lützhøft, Stefan Tiefenbacher, Wan Hui Ong Clausen

Publikováno v: Haemophilia

Aim N8‐GP (turoctocog alfa pegol) is a glycoPEGylated, extended half‐life human recombinant factor VIII (FVIII) shown to be an efficacious treatment for patients with haemophilia A. Accurate monitoring of replacement therapy helps ensure proper d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b9b695a6f4909e7df9a2895347cb984
http://europepmc.org/articles/PMC6852407

Measuring factor VIII activity in samples from patients treated with N8-GP (Esperoct

Autor: Judi, Møss, Wan Hui Ong, Clausen, Mirella, Ezban

Publikováno v: Haemophilia : the official journal of the World Federation of Hemophilia. 27(3)

FVIII activity in samples taken at various time points from 21 patients treated with N8-GP (Esperoct

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::1f150d9f42adb8873591f4cc2a158a2d
https://pubmed.ncbi.nlm.nih.gov/33314455

Pharmacokinetics of a novel extended half-life glycoPEGylated factor IX, nonacog beta pegol (N9-GP) in previously treated patients with haemophilia B: results from two phase 3 clinical trials

Autor: Elena Santagostino, Manuel Carcao, Wan Hui Ong Clausen, Susan Kearney, Johannes Oldenburg, Guy Young, Andreas Tiede, Tadashi Matsushita, Peter Persson, Claude Negrier, F. Abdul-Karim

Publikováno v: Haemophilia. 23:547-555

Introduction Nonacog beta pegol (N9-GP) is a glycoPEGylated recombinant factor IX (FIX) with an extended half-life developed for routine prophylaxis and the prevention and treatment of bleeding episodes in patients with haemophilia B. Aim The aim of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3ff90dc5a1d1df5e0ca1dfb5cfd1b3e8
https://doi.org/10.1111/hae.13191

Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A

Autor: A. Tiede, Paul Giangrande, K. Hampton, T. Lambert, Meera Chitlur, L. Alberio, C. Negrier, H. Takedani, Michael Recht, S. Lentz, Woei Tsay, S. Dunkley, Miguel A. Escobar, T. Fujii, P. Kampmann, Christine M. Knoll, M. Shima, T. A. Andreeva, Peter G. Jönsson, Steven R. Lentz, Chris Barnes, L. Nemes, Johannes Oldenburg, K. Fukutake, B. Brand, H. Hanabusa, Elena Santagostino, M. Guerrera, E. Cockrell, Tadashi Matsushita, Jerry S. Powell, Lone Hvitfeldt Poulsen, Ralph A. Gruppo, Laszlo Nemes, J. Morales, C. Rothschild, G. Thomson, P. Chowdary, J. Felgenhauer, S. Zupancic-Salek, J. Sathar, N. Apollonsky, A. Tosetto, Roshni Kulkarni, J. Lazarchick, E. M. Mingot, S. Madoiwa, M. Misgav, V Jiménez Yuste, Z. Boda, K. Meijer, E. Zetterberg, G. K. Guron, M. Castro Ozelo, G. R. Nagasubramanian, S. Kearney, Pratima Chowdary, J. Oldenburg, C. Albayrak, Frank W.G. Leebeek, Silke Ehrenforth, Savita Rangarajan, Tatiana Andreeva, K. Kavakli, H. Eichler, L. H. Poulsen, Faraizah Abdul Karim, A. Kutlar, J. Wright, M. Trossaert, P. Kavasch, M. C. Shen, Chur Woo You, P. A. Holme, E. Santagostino, Wan Hui Ong Clausen, N. Curry, I. Sasmaz, W. Miesbach, A. Shibuya, A. Paroskie-Wheeler, E. Lowe, Clifford M Takemoto, D. Yee, F. Boehlen, S. Brown, F. W. G. Leebeek, J. Lasky, Peter William Collins, T. Sato, Robert Klamroth, K. Dunsmore

Publikováno v: Thrombosis and Haemostasis, 117(2), 252-261. Georg Thieme Verlag
Giangrande, P, Andreeva, T, Chowdary, P, Ehrenforth, S, Hanabusa, H, Leebeek, F W G, Lentz, S R, Nemes, L, Poulsen, L H, Santagostino, E, You, C W, Clausen, W H O, Jönsson, P G, Oldenburg, J & Pathfinder™2 Investigators 2017, ' Clinical evaluation of glycoPEGylated recombinant FVIII : Efficacy and safety in severe haemophilia A ', Thrombosis and Haemostasis, pp. 252-261 . https://doi.org/10.1160/TH16-06-0444

Turoctocog alfa pegol (N8-GP) is a novel glycoPEGylated extended half-life recombinant factor VIII (FVIII) product developed for prophylaxis and treatment of bleeds in patients with haemophilia A, to enable higher activity levels with less frequent i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::deca7c652b62e159aa11378000e7fe8c
https://pure.eur.nl/en/publications/5f120d71-685a-4410-9b98-59e6346a7976