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Items: 1 to 20 of 105

1.

Pharmacokinetics and pharmacodynamics of turoctocog alfa and N8-GP in haemophilia A dogs.

Agersø H, Stennicke HR, Pelzer H, Olsen EN, Merricks EP, Defriess NA, Nichols TC, Ezban M.

Haemophilia. 2012 Nov;18(6):941-7. doi: 10.1111/j.1365-2516.2012.02896.x. Epub 2012 Jul 20.

2.

Factor VIII chromogenic assays can be used for potency labeling and postadministration monitoring of N8-GP.

Pickering W, Hansen M, Kjalke M, Ezban M.

J Thromb Haemost. 2016 Aug;14(8):1579-87. doi: 10.1111/jth.13375. Epub 2016 Aug 2.

PMID:
27241682
3.

Prolonged effect of a new O-glycoPEGylated FVIII (N8-GP) in a murine saphenous vein bleeding model.

Pastoft AE, Ezban M, Tranholm M, Lykkesfeldt J, Lauritzen B.

Haemophilia. 2013 Nov;19(6):913-9. doi: 10.1111/hae.12198. Epub 2013 Jun 4.

PMID:
23730746
4.

The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight®), in patients with hemophilia A.

Jiménez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Møss J.

J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13. Review.

5.

Pharmacokinetics and ex vivo whole blood clot formation of a new recombinant FVIII (N8) in haemophilia A dogs.

Karpf DM, Kjalke M, Thim L, Agersø H, Merricks EP, Defriess N, Nichols TC, Ezban M.

Haemophilia. 2011 Sep;17(5):e963-8. doi: 10.1111/j.1365-2516.2011.02580.x. Epub 2011 Jun 20.

6.

Measuring FVIII activity of glycopegylated recombinant factor VIII, N8-GP, with commercially available one-stage clotting and chromogenic assay kits: a two-centre study.

Hillarp A, Bowyer A, Ezban M, Persson P, Kitchen S.

Haemophilia. 2017 May;23(3):458-465. doi: 10.1111/hae.13168. Epub 2017 Feb 14.

PMID:
28198071
7.

Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A.

Meunier S, Alamelu J, Ehrenforth S, Hanabusa H, Abdul Karim F, Kavakli K, Khodaie M, Staber J, Stasyshyn O, Yee DL, Rageliene L.

Thromb Haemost. 2017 Aug 30;117(9):1705-1713. doi: 10.1160/TH17-03-0166. Epub 2017 Jul 6.

PMID:
28692108
8.

Development of a tail vein transection bleeding model in fully anaesthetized haemophilia A mice - characterization of two novel FVIII molecules.

Johansen PB, Tranholm M, Haaning J, Knudsen T.

Haemophilia. 2016 Jul;22(4):625-31. doi: 10.1111/hae.12907. Epub 2016 Mar 3.

PMID:
26936336
9.

Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A.

Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D.

J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161.

10.

Turoctocog alfa (NovoEight®)--from design to clinical proof of concept.

Ezban M, Vad K, Kjalke M.

Eur J Haematol. 2014 Nov;93(5):369-76. doi: 10.1111/ejh.12366. Epub 2014 May 28. Review.

11.

First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A.

Hampton K, Chowdary P, Dunkley S, Ehrenforth S, Jacobsen L, Neff A, Santagostino E, Sathar J, Takedani H, Takemoto CM, Négrier C.

Haemophilia. 2017 Sep;23(5):689-696. doi: 10.1111/hae.13246. Epub 2017 May 4.

PMID:
28470862
12.

Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics.

Kulkarni R, Karim FA, Glamocanin S, Janic D, Vdovin V, Ozelo M, Rageliene L, Carboni E, Laguna P, Dobaczewski G, Seremetis S, Lindblom A, Santagostino E.

Haemophilia. 2013 Sep;19(5):698-705. doi: 10.1111/hae.12165. Epub 2013 May 8.

PMID:
23651313
13.

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

Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jönsson PG, Oldenburg J; Pathfinder™2 Investigators.

Thromb Haemost. 2017 Jan 26;117(2):252-261. doi: 10.1160/TH16-06-0444. Epub 2016 Dec 1.

PMID:
27904904
14.

Turoctocog alfa: an evidence-based review of its potential in the treatment of hemophilia A.

Takedani H, Hirose J.

Drug Des Devel Ther. 2015 Mar 24;9:1767-72. doi: 10.2147/DDDT.S57967. eCollection 2015. Review.

15.

Pharmacokinetics and pharmacodynamics of a new recombinant FVIII (N8) in haemophilia A mice.

Elm T, Karpf DM, Øvlisen K, Pelzer H, Ezban M, Kjalke M, Tranholm M.

Haemophilia. 2012 Jan;18(1):139-45. doi: 10.1111/j.1365-2516.2011.02608.x. Epub 2011 Jul 19.

PMID:
21771205
16.

Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy.

Lentz SR, Misgav M, Ozelo M, Salek SZ, Veljkovic D, Recht M, Cerqueira M, Tiede A, Brand B, Mancuso ME, Seremetis S, Lindblom A, Martinowitz U.

Haemophilia. 2013 Sep;19(5):691-7. doi: 10.1111/hae.12159. Epub 2013 May 7.

PMID:
23647704
17.

Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE®)--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A.

Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D.

Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.

PMID:
21443634
18.

Pharmacokinetics, tissue distribution and excretion of 40kDa PEG and PEGylated rFVIII (N8-GP) in rats.

Bjørnsdottir I, Sternebring O, Kappers WA, Selvig H, Kornø HT, Kristensen JB, Bagger MA.

Eur J Pharm Sci. 2016 May 25;87:58-68. doi: 10.1016/j.ejps.2015.10.020. Epub 2015 Oct 27.

19.

Turoctocog alfa for the treatment of hemophilia a.

Vakil NH, Fujinami N, Martin-Stone S.

Pharmacotherapy. 2014 Oct;34(10):1091-101. doi: 10.1002/phar.1469. Epub 2014 Jul 23. Review.

PMID:
25052207
20.

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.

Santagostino E, Lentz SR, Misgav M, Brand B, Chowdary P, Savic A, Kilinc Y, Amit Y, Amendola A, Solimeno LP, Saugstrup T, Matytsina I.

Haemophilia. 2015 Jan;21(1):34-40. doi: 10.1111/hae.12518. Epub 2014 Oct 2.

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