Overcoming delayed in-vitro response to rFVIIa: Effects of rFVIIa and rFVIIa analogue (vatreptacog alfa) concentration escalation in whole blood assays

Blood Coagulation and Fibrinolysis

Volumn 22, Issue 6, 2011, Pages 541-546

  Brophy, Donald F ^a   Martin, Erika J ^a   Barrett, J Christian ^a   Nolte, Melinda E ^a   Kuhn, Janice G ^a   Hedner, Ulla ^b   Ezban, Mirella ^c  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b LUND UNIVERSITY   (Sweden)

^c NOVO NORDISK A S   (Denmark)

Author keywords

hemodyne; hemophilia; platelets; rFVIIa (NovoSeven); rFVIIa analogue (vatreptacog alfa); ROTEM; thromboelastography

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; DESMOPRESSIN; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9;

ADULT; ARTICLE; BLEEDING; BLOOD ANALYSIS; BLOOD CLOTTING; BLOOD CLOTTING TIME; CLINICAL ARTICLE; DOSE RESPONSE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFECT; DRUG MEGADOSE; HEMOPHILIA; HEMOSTASIS; HUMAN; IN VITRO STUDY; PRIORITY JOURNAL; TREATMENT RESPONSE; YOUNG MODULUS;

ADULT; BLOOD COAGULATION; BLOOD COAGULATION TESTS; BLOOD PLATELETS; CELLS, CULTURED; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR VIIA; HEMOPHILIA A; HUMANS; MIDDLE AGED; RECOMBINANT PROTEINS; THROMBELASTOGRAPHY; TIME FACTORS; VIRGINIA;

EID: 80052102936     PISSN: 09575235     EISSN: 14735733     Source Type: Journal    
DOI: 10.1097/MBC.0b013e328348d9e5     Document Type: Article

References (23)

1. Hedner U, Lee CA. First 20 years with recombinant FVIIa (NovoSeven). Haemophilia 2011; 17:172-182.
2. Shapiro AD, Gilchrist GS, Hoots WK, Cooper HA, Gastineau DA. Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost 1998; 80:773-778. (Pubitemid 28521721)
3. Abshire T, Kenet G. Recombinant factor VIIa: review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors. J Thromb Haemost 2004; 2:899-909. (Pubitemid 40185737)
4. Schneiderman J, Rubin E, Nugent DJ, Young G. Sequential therapy with activated prothrombin complex concentrates and recombinant FVIIa in patients with severe haemophilia and inhibitors: update of our previous experience. Haemophilia 2007; 13:244-248. (Pubitemid 46746046)
5. Young G, Shafer FE, Rojas P, SeremetisS. Single 270 microg kg(-1)-dose FVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia 2008; 14:287-294. (Pubitemid 351338689)
6. Hayashi T, Tanaka I, Shima M, Yoshida K, Fukuda K, Sakurai Y, et al. Unresponsiveness to factor VIII inhibitor bypassing agents during haemostatic treatment for life-threatening massive bleeding in a patient with haemophilia A and a high responding inhibitor. Haemophilia 2004; 10:397-400. (Pubitemid 39077041)
7. Persson E, Kjalke M, Olsen OH. Rational design of coagulation factor VIIa variants with substantially increased intrinsic activity. Proc Natl Acad Sci USA 2001; 98:13583-13588. (Pubitemid 33115941)
8. Allen GA, Persson E, Campbell RA, Ezban M, Hedner U, Wolberg AS. A variant of recombinant factor VIIa with enhanced procoagulant and antifibrinolytic activities in an in vitro model of hemophilia. Arterioscler Thromb Vasc Biol 2007; 27:683-689.
9. Brophy DF, Martin EJ, Nolte ME, Kuhn JG, Carr ME. Effect of recombinant factor VIIa variant (NN1731) on platelet function, clot structure and force onset time in whole blood from healthy volunteers and haemophilia patients. Haemophilia 2007; 13:533-541. (Pubitemid 47337993)
10. Brophy DF, Martin EJ, Nolte ME, Kuhn J, Barrett JC, Ezban M. Factor VIIA analog has marked effects on platelet function and clot kinetics in blood from patients with hemophilia A. Blood Coagul Fibrinolysis 2010; 21:539-546.
11. Holmberg HL, Lauritzen B, Tranholm M, Ezban M. Faster onset of effect and greater efficacy of NN1731 compared with rFVIIa, aPCC and FVIII in tail bleeding in hemophilic mice. J Thromb Haemost 2009; 7:1517-1522.
12. de Paula E. Safety and preliminary efficacy of recombinant activated FVII analog (NN1731) in the treatment of joint bleeds In congenital hemophilia patients with inhibitors. 2010 Annual Meeting of the American Society of Hematology [Abstract 719].
13. -1 dosing in haemophiliacs: comparing laboratory response using various whole blood assays over 6 h. Haemophilia 2011. doi: 10.1111/j.1365-2516.2011.02492.x. [Epub ahead of print].
14. Agersø H, Brophy DF, Pelzer H, Martin EJ, Carr M, Hedner U, Ezban M. Recombinant human factor VIIa (rFVIIa) cleared principally by antithrombin following intravenous administration in hemophilia patients. J Thromb Haemost 2011; 9:333-338.
15. World Medical Association. Declaration of Helsinki: ethical principles for research involving human subjects. As amended in Tokyo 2004. Ferney-Voltaire, France: The Association; 2004. Available: www.wma.net/e/ ethicsunit/helsinki.htm (Accessed March 11, 2011).
16. Carr ME, Martin EJ, Kuhn JG, Spiess BD. Onset of force development as a marker of thrombin generation in whole blood: the thrombin generation time (TGT). J Thromb Haemost 2003; 1:1977-1983.
17. Carr ME Jr. Development of platelet contractile force as a research and clinical measure of platelet function. Cell Biochem Biophys 2003; 38:55-78. (Pubitemid 41270823)
18. Sørensen B, Persson E, Ingerslev J. Factor VIIa analogue (V158D/E296/M298Q-FVIIa) normalises clot formation in whole blood from patients with severe haemophilia A. Br J Haematol 2007; 137:158-165. (Pubitemid 46474712)
19. Young G, Ebbesen LS, Viuff D, Di Paola J, Konkle BA, Negrier C, et al. Evaluation of thromboelastography for monitoring recombinant activated factor VII ex vivo in haemophilia A and B patients with inhibitors: a multicentre trial. Blood Coagul Fibrinolysis 2008; 19:276-282. (Pubitemid 351670411)
20. He S, Ezban M, Bark N, Persson E, Hedner U. Fibrin gel structure obtained with a FVIIa analogue with enhanced FX-activating potential in haemophilia. Thromb Haemost 2009; 102:790-792.
21. Lauritzen B, Viuff D, Tranholm M, Ezban M. rFVIIa and NN1731 reduce bleeding in hydroxymethyl starch hemodiluted rabbits. J Trauma 2010; 69:1196-1202.
22. Weeterings C, Lison T, de Groot PG. Tissue factor-independent effects of recombinant factor VIIa on hemostasis. Semin Hematol 2008; 45 (2Suppl 1):S12-S15. (Pubitemid 351787689)
23. Hoffman M, Volovyk Z, Persson E, Gabriel DA, Ezban M, Monroe DM. Platelet binding and activity of a factor VIIa variant with enhanced tissue factor independent activity. J Thromb Haemost 2011; 9:759-766.