Turoctocog alfa for the treatment of hemophilia A

Drugs of Today

Volumn 50, Issue 2, 2014, Pages 121-131

  Haddley, Kate ^a  

^a NONE

Author keywords

Coagulation factor VIII deficiency; Hemophilia a; Recombinant coagulation factor VIII; Turoctocog alfa

Indexed keywords

DESMOPRESSIN; RECOMBINANT BLOOD CLOTTING FACTOR 8; TRANEXAMIC ACID;

ARTICLE; DRUG EFFICACY; DRUG MANUFACTURE; DRUG SAFETY; DRUG SCREENING; HEMOPHILIA A; HUMAN; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; OPERATIVE BLOOD LOSS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC);

COAGULATION FACTOR VIII DEFICIENCY; HEMOPHILIA A; RECOMBINANT COAGULATION FACTOR VIII; TUROCTOCOG ALFA;

ANIMALS; CLINICAL TRIALS, PHASE III AS TOPIC; FACTOR VIII; HEMOPHILIA A; HUMANS; INTRAOPERATIVE COMPLICATIONS; RECOMBINANT PROTEINS;

EID: 84896091670     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2014.50.2.2116671     Document Type: Article

References (27)

1. Fijnvandraat, K., Cnossen, M.H., Leebeek, F.W.G., Peters, M. Diagnosis and management of haemophilia. BMJ 2012, 344: e2707-11.
2. Howard, E.L., Becker, K.C.D., Rusconi, CP., Becker, RC. Factor IXa inhibitors as novel anticoagulants. Arterioscler Thromb Vasc Biol 2007, 27(4): 722-27. (Pubitemid 46606698)
3. Lawn, R.M. The molecular genetics of hemophilia: Blood clotting factors VIII and IX. Cell 1985, 42: 405-6.
4. Thim, L., Vandahl, B., Karlsson, J. et al. Purification and characterization of a new recombinant factor VIII (N8). Haemophilia 2010, 16(2): 349-59.
5. White, G.C., Rosendaal, F., Aledort, L.M., Lusher, J.M., Rothschild, C., Ingerslev, J. Definitions in hemophilia. Recommendation of the scientific subcommittee on factor VIII and factor IX of the scientific and standardization committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost 2001, 85(3): 560. (Pubitemid 32233035)
6. Keeling, D., Tait, C., Makris, M. Guideline on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. A United Kingdom Haemophilia Center Doctors' Organization (UKHCDO) guideline approved by the British Committee for Standards in Haematology. Haempophilia 2008, 14(4): 671-84.
7. Hansen, J.J., Bolt, G., Kjaergaard, K., Kristensen, C. et al. Generation of recombinant FVIII purification antibody for manufacturing of N8. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-WE-572.
8. Thim, L., Vandahl, B.S., Karlsson, J., Klausen, N.K. et al. Purification and characterisation of a new recombinant FVIII (N8). 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-MO-565.
9. Gruhler, A., Vandahl, B., Kjalke, M. Characterization of a new recombinant FVIII (N8) with anti-FVIII monoclonal antibodies (MAB). 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-MO-558.
10. Christiansen, M.L.S., Balling, K.W., Persson, E. et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia 2010, 16(6): 878-87.
11. Kjalke, M., Bagger-Soerensen, A., Larsen, L.F. et al. In Vitro activity of N8, a new recombinant FVIII compound. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-MO-580.
12. Balling, K.W, Kjalke, M. Activation and inactivation rates of a new recombinant FVIII (N8) are similar to FVIII expressed as full length molecule. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-WE-582.
13. Kjalke, M., Christiansen, M.S., Balling, K.W. et al. Functional characterization of a new recombinant FVIII (N8). 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-WE-589.
14. Karpf, DM., Kjalke, M., Steenstrup, TD., et al. Pharmacokinetic (PK) evaluation of a new rFVIII (N8) after i.v. administration of different dose levels to FVIII knock-out mice. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-MO-569.
15. Elm, R., Kjalke, M., Pelzer, H., Tranholm, M. Efficacy of a new recombinant FVIII (N8) in a tail bleeding model in hemophilia A mice. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-TH-594.
16. Karpf, D.M., Kjalke, M., Pelzer, H. et al. Pharmacokinetic (PK) and pharmacodynamic (PD) properties of a new recombinant FVIII (N8) in hemophilia a dogs. 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-MO-570.
17. Agerso, H., Stennicke, H.R., Pelzer, H. et al. Pharmacokinetics and pharmacodynamics of turoctocog alfa and N8-GP in haemophilia A dogs. Haemophilia 2012, 18(6): 941.
18. Christiansen, M.L.S., Sorensen, B.B., Viuff, D., Kjalke, M. et al. Effect of a new rFVIII compound N8 using blood from hemophilia A (HA) patients evaluated by thromboelastography (TEC). 22nd Congr Int Soc Thromb Haemost (ISTH) (July 11-16, Boston) 2009, Abst PP-WE-591.
19. Martinowitz, U., Bjerre, J., Brand, B. et al. 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. Haemophilia 2011, 17(6): 854-59.
20. Lentz, S.R., Misgav, M., Ozelo, M. et al. Results from a large multinational clinical trial (guardianTM1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia 2013, 19: 691-97.
21. Andreeva, T., Suzuki, T., Nielsen, R., Andersen, E., Lindblom, A. The influence of co-morbidities on annualised bleeding rates in patients with severe haemophilia A: Experiences from the pivotal turoctocog alfa prophylaxis trial (Guardian 1). 24th Congr Int Soc Thromb Haemost (ISTH) (June 29-July 4, Amsterdam) 2013, Abst PB 1.37-6.
22. Ozelo, M.C., Veljkovic, D., Klamroth, R., Misgav, M., Nielsen, R., Groth, A. Association between predicted FVIII levels and risk of bleeding episodes in clinical trials with turoctocog alfa, a new rFVIII product from Novo Nordisk. 24th Congr Int Soc Thromb Haemost (ISTH) (June 29-July 4, Amsterdam) 2013, Abst PA 2.06-5.
23. Kulkarni, R., Karim, F.A., Glamocanin, S. et al. Results from a large multinational clinical trial (guardianTM3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia 2013, 19: 698-705.
24. Turoctocog alfa. Trial ID: NN7008-3600. Clinical trial report synopsis. Novo Nordisk, April 12, 2012. http://www.novonordisk-trials.com/Website/pdf/ registry/bin-20131213-061422-735.pdf. Accessed February 19, 2014.
25. Turoctocog alfa. Trial ID: NN7008-3893. Clinical trial report synopsis. Novo Nordisk, April 30, 2012. http://www.novonordisk-trials.com/Website/pdf/ registry/bin-20131213-061930-004.pdf. Accessed February 19, 2014.
26. Turoctocog alfa. Trial ID: NN7008-4015. Clinical trial report synopsis. Novo Nordisk, August 27, 2013. http://www.novonordisk-trials.com/Website/pdf/ registry/bin-20131213-062403-508.pdf. Accessed February 19, 2014.
27. Santagostino, E., Lentz, SR., Misgav, M. et al. Surgery with turoctocog alfa: Efficacy and safety in bleeding prevention during surgical procedures - Results from the Guardian trials. 54th Annu Meet Am Soc Hematol (December 8-11, Atlanta) 2012, Abst 2228.