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Volumn 12, Issue 8, 2014, Pages 1302-1312

Predicting dosing advantages of factor VIIa variants with altered tissue factor-dependent and lipid-dependent activities

Author keywords

Factor VIIa; Hemophilia; Pharmacology; Thrombin; Thromboplastin

Indexed keywords

ENZYME PRECURSOR; LIPID; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBOPLASTIN; BLOOD CLOTTING FACTOR 7A; RECOMBINANT PROTEIN;

EID: 84906101602     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12628     Document Type: Article
Times cited : (10)

References (50)
  • 1
    • 0035200558 scopus 로고    scopus 로고
    • The action of high-dose factor VIIa (FVIIa) in a cell-based model of hemostasis
    • Hoffman M, Monroe DM III. The action of high-dose factor VIIa (FVIIa) in a cell-based model of hemostasis. Semin Hematol 2001; 38: 6-9.
    • (2001) Semin Hematol , vol.38 , pp. 6-9
    • Hoffman, M.1    Monroe III, D.M.2
  • 2
    • 84864421953 scopus 로고    scopus 로고
    • A novel FVIIa variant with increased potency and duration of effect compared to wildtype FVIIa. A study in a dog model of hemophilia A
    • Pittman D, Weston S, Shields K, Parng C, Arkin S, Madison E, Nichols TC, Fruebis J. A novel FVIIa variant with increased potency and duration of effect compared to wildtype FVIIa. A study in a dog model of hemophilia A. Blood 2011; 118: 2252.
    • (2011) Blood , vol.118 , pp. 2252
    • Pittman, D.1    Weston, S.2    Shields, K.3    Parng, C.4    Arkin, S.5    Madison, E.6    Nichols, T.C.7    Fruebis, J.8
  • 4
    • 0035923721 scopus 로고    scopus 로고
    • Rational design of coagulation factor VIIa variants with substantially increased intrinsic activity
    • 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: 13583-8.
    • (2001) Proc Natl Acad Sci USA , vol.98 , pp. 13583-13588
    • Persson, E.1    Kjalke, M.2    Olsen, O.H.3
  • 5
    • 33847054740 scopus 로고    scopus 로고
    • A variant of recombinant factor VIIa with enhanced procoagulant and antifibrinolytic activities in an in vitro model of hemophilia
    • 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: 683-9.
    • (2007) Arterioscler Thromb Vasc Biol , vol.27 , pp. 683-689
    • Allen, G.A.1    Persson, E.2    Campbell, R.A.3    Ezban, M.4    Hedner, U.5    Wolberg, A.S.6
  • 6
    • 84860457217 scopus 로고    scopus 로고
    • Phase I randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia
    • Mahlangu JN, Coetzee MJ, Laffan M, Windyga J, Yee TT, Schroeder J, Haaning J, Siegel JE, Lemm G. Phase I randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia. J Thromb Haemost 2012; 10: 773-80.
    • (2012) J Thromb Haemost , vol.10 , pp. 773-780
    • Mahlangu, J.N.1    Coetzee, M.J.2    Laffan, M.3    Windyga, J.4    Yee, T.T.5    Schroeder, J.6    Haaning, J.7    Siegel, J.E.8    Lemm, G.9
  • 8
    • 84906100921 scopus 로고    scopus 로고
    • Factor VIIa-CTP, a novel long-acting coagulation factor, displays a prolonged hemostatic effect and augmented pharmacokinetics and pharmacodynamics following IV and SC administration in hemophilic animal models
    • Hart G, Hershkovitz O, Bar-Ilan A, Seligsohn U, Fima E. Factor VIIa-CTP, a novel long-acting coagulation factor, displays a prolonged hemostatic effect and augmented pharmacokinetics and pharmacodynamics following IV and SC administration in hemophilic animal models. Blood 2012; 120: 1114.
    • (2012) Blood , vol.120 , pp. 1114
    • Hart, G.1    Hershkovitz, O.2    Bar-Ilan, A.3    Seligsohn, U.4    Fima, E.5
  • 10
    • 84880198215 scopus 로고    scopus 로고
    • 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics, and preliminary efficacy in hemophilia patients with inhibitors
    • Ljung R, Karim FA, Saxena K, Suzuki T, Arkhammar P, Rosholm A, Giangrande P. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics, and preliminary efficacy in hemophilia patients with inhibitors. J Thromb Haemost 2013; 11: 1260-8.
    • (2013) J Thromb Haemost , vol.11 , pp. 1260-1268
    • Ljung, R.1    Karim, F.A.2    Saxena, K.3    Suzuki, T.4    Arkhammar, P.5    Rosholm, A.6    Giangrande, P.7
  • 12
    • 84906101322 scopus 로고    scopus 로고
    • The New and Improved (?) Activated Factor VII Molecules. Accessed 18 June 2014.
    • Retzios AD. The New and Improved (?) Activated Factor VII Molecules. http://adrclinresearch.com/Issues_in_Clinical_Research_links/The%20New%20Factor%20VIIas_18May2011.pdf. Accessed 18 June 2014.
    • Retzios, A.D.1
  • 13
    • 84868152441 scopus 로고    scopus 로고
    • Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX
    • Collins PW, Moss J, Knobe K, Groth A, Colberg T, Watson E. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost 2012; 10: 2305-12.
    • (2012) J Thromb Haemost , vol.10 , pp. 2305-2312
    • Collins, P.W.1    Moss, J.2    Knobe, K.3    Groth, A.4    Colberg, T.5    Watson, E.6
  • 16
    • 78049295599 scopus 로고    scopus 로고
    • Safety, pharmacokinetics and efficacy of factor VIIa formulated with PEGylated liposomes in haemophilia A patients with inhibitors to factor VIII - an open label, exploratory, cross-over, phase I/II study
    • Spira J, Plyushch O, Zozulya N, Yatuv R, Dayan I, Bleicher A, Robinson M, Baru M. Safety, pharmacokinetics and efficacy of factor VIIa formulated with PEGylated liposomes in haemophilia A patients with inhibitors to factor VIII - an open label, exploratory, cross-over, phase I/II study. Haemophilia 2010; 16: 910-18.
    • (2010) Haemophilia , vol.16 , pp. 910-918
    • Spira, J.1    Plyushch, O.2    Zozulya, N.3    Yatuv, R.4    Dayan, I.5    Bleicher, A.6    Robinson, M.7    Baru, M.8
  • 17
    • 78650492660 scopus 로고    scopus 로고
    • Prospective assessment of thrombin generation test for dose monitoring of bypassing therapy in hemophilia patients with inhibitors undergoing elective surgery
    • Dargaud Y, Lienhart A, Negrier C. Prospective assessment of thrombin generation test for dose monitoring of bypassing therapy in hemophilia patients with inhibitors undergoing elective surgery. Blood 2010; 116: 5734-7.
    • (2010) Blood , vol.116 , pp. 5734-5737
    • Dargaud, Y.1    Lienhart, A.2    Negrier, C.3
  • 18
    • 84864445333 scopus 로고    scopus 로고
    • Unifying the mechanism of recombinant FVIIa action: dose dependence is regulated differently by tissue factor and phospholipids
    • Shibeko AM, Woodle SA, Lee TK, Ovanesov MV. Unifying the mechanism of recombinant FVIIa action: dose dependence is regulated differently by tissue factor and phospholipids. Blood 2012; 120: 891-9.
    • (2012) Blood , vol.120 , pp. 891-899
    • Shibeko, A.M.1    Woodle, S.A.2    Lee, T.K.3    Ovanesov, M.V.4
  • 22
    • 84863546447 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of rFVIIa and new improved bypassing agents for the treatment of haemophilia
    • Agerso H, Tranholm M. Pharmacokinetics and pharmacodynamics of rFVIIa and new improved bypassing agents for the treatment of haemophilia. Haemophilia 2012; 18: 6-10.
    • (2012) Haemophilia , vol.18 , pp. 6-10
    • Agerso, H.1    Tranholm, M.2
  • 25
    • 77958575112 scopus 로고    scopus 로고
    • Combination of FVIII and by-passing agent potentiates in vitro thrombin production in haemophilia A inhibitor plasma
    • Klintman J, Astermark J, Berntorp E. Combination of FVIII and by-passing agent potentiates in vitro thrombin production in haemophilia A inhibitor plasma. Br J Haematol 2010; 151: 381-6.
    • (2010) Br J Haematol , vol.151 , pp. 381-386
    • Klintman, J.1    Astermark, J.2    Berntorp, E.3
  • 26
    • 61349201697 scopus 로고    scopus 로고
    • The effect of tissue factor concentration on calibrated automated thrombography in the presence of inhibitor bypass agents
    • van Veen JJ, Gatt A, Bowyer AE, Cooper PC, Kitchen S, Makris M. The effect of tissue factor concentration on calibrated automated thrombography in the presence of inhibitor bypass agents. Int J Lab Hematol 2009; 31: 189-98.
    • (2009) Int J Lab Hematol , vol.31 , pp. 189-198
    • van Veen, J.J.1    Gatt, A.2    Bowyer, A.E.3    Cooper, P.C.4    Kitchen, S.5    Makris, M.6
  • 27
    • 77951667197 scopus 로고    scopus 로고
    • Combining FVIIa and FX into a mixture which imparts a unique thrombin generation potential to hemophilic plasma: an in vitro assessment of FVIIa/FX mixture as an alternative bypassing agent
    • Nakatomi Y, Nakashima T, Gokudan S, Miyazaki H, Tsuji M, Hanada-Dateki T, Araki T, Tomokiyo K, Hamamoto T, Ogata Y. Combining FVIIa and FX into a mixture which imparts a unique thrombin generation potential to hemophilic plasma: an in vitro assessment of FVIIa/FX mixture as an alternative bypassing agent. Thromb Res 2010; 125: 457-63.
    • (2010) Thromb Res , vol.125 , pp. 457-463
    • Nakatomi, Y.1    Nakashima, T.2    Gokudan, S.3    Miyazaki, H.4    Tsuji, M.5    Hanada-Dateki, T.6    Araki, T.7    Tomokiyo, K.8    Hamamoto, T.9    Ogata, Y.10
  • 28
    • 79955429941 scopus 로고    scopus 로고
    • A highly sensitive thrombin generation assay for assessment of recombinant activated factor VII therapy in haemophilia patients with an inhibitor
    • Livnat T, Martinowitz U, Zivelin A, Rima D, Kenet G. A highly sensitive thrombin generation assay for assessment of recombinant activated factor VII therapy in haemophilia patients with an inhibitor. Thromb Haemost 2011; 105: 688-95.
    • (2011) Thromb Haemost , vol.105 , pp. 688-695
    • Livnat, T.1    Martinowitz, U.2    Zivelin, A.3    Rima, D.4    Kenet, G.5
  • 29
    • 67649868161 scopus 로고    scopus 로고
    • Concomitant infusion of low doses of rFVIIa and FEIBA in haemophilia patients with inhibitors
    • Martinowitz U, Livnat T, Zivelin A, Kenet G. Concomitant infusion of low doses of rFVIIa and FEIBA in haemophilia patients with inhibitors. Haemophilia 2009; 15: 904-10.
    • (2009) Haemophilia , vol.15 , pp. 904-910
    • Martinowitz, U.1    Livnat, T.2    Zivelin, A.3    Kenet, G.4
  • 30
    • 84879461542 scopus 로고    scopus 로고
    • Real-world outcomes with recombinant factor VIIa treatment of acute bleeds in haemophilia patients with inhibitors: results from the international ONE registry
    • Chambost H, Santagostino E, Laffan M, Kavakli K. Real-world outcomes with recombinant factor VIIa treatment of acute bleeds in haemophilia patients with inhibitors: results from the international ONE registry. Haemophilia 2013; 19: 571-7.
    • (2013) Haemophilia , vol.19 , pp. 571-577
    • Chambost, H.1    Santagostino, E.2    Laffan, M.3    Kavakli, K.4
  • 31
    • 33645750469 scopus 로고    scopus 로고
    • Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial
    • Kavakli K, Makris M, Zulfikar B, Erhardtsen E, Abrams ZS, Kenet G. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial. Thromb Haemost 2006; 95: 600-5.
    • (2006) Thromb Haemost , vol.95 , pp. 600-605
    • Kavakli, K.1    Makris, M.2    Zulfikar, B.3    Erhardtsen, E.4    Abrams, Z.S.5    Kenet, G.6
  • 32
    • 33645573977 scopus 로고    scopus 로고
    • A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors
    • Santagostino E, Mancuso ME, Rocino A, Mancuso G, Scaraggi F, Mannucci PM. A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors. J Thromb Haemost 2006; 4: 367-71.
    • (2006) J Thromb Haemost , vol.4 , pp. 367-371
    • Santagostino, E.1    Mancuso, M.E.2    Rocino, A.3    Mancuso, G.4    Scaraggi, F.5    Mannucci, P.M.6
  • 33
    • 65449158359 scopus 로고    scopus 로고
    • -1) recombinant activated factor VII for the treatment and prevention of bleeds in haemophilia A patients with inhibitors: experience from seven European haemophilia centres
    • -1) recombinant activated factor VII for the treatment and prevention of bleeds in haemophilia A patients with inhibitors: experience from seven European haemophilia centres. Haemophilia 2009; 15: 760-5.
    • (2009) Haemophilia , vol.15 , pp. 760-765
    • Pan-Petesch, B.1    Laguna, P.2    Mital, A.3    Stanley, J.4    Torchet, M.F.5    Salek, S.Z.6    Salaj, P.7
  • 34
    • 40349085780 scopus 로고    scopus 로고
    • -1-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison
    • -1-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia 2008; 14: 287-94.
    • (2008) Haemophilia , vol.14 , pp. 287-294
    • Young, G.1    Shafer, F.E.2    Rojas, P.3    Seremetis, S.4
  • 35
    • 78651426822 scopus 로고    scopus 로고
    • Use of recombinant factor VIIa for the prevention and treatment of bleeding in patients without hemophilia: a systematic review and meta-analysis
    • Lin Y, Stanworth S, Birchall J, Doree C, Hyde C. Use of recombinant factor VIIa for the prevention and treatment of bleeding in patients without hemophilia: a systematic review and meta-analysis. CMAJ 2011; 183: E9-19.
    • (2011) CMAJ , vol.183
    • Lin, Y.1    Stanworth, S.2    Birchall, J.3    Doree, C.4    Hyde, C.5
  • 36
    • 0031743504 scopus 로고    scopus 로고
    • Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery
    • 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: 773-8.
    • (1998) Thromb Haemost , vol.80 , pp. 773-778
    • Shapiro, A.D.1    Gilchrist, G.S.2    Hoots, W.K.3    Cooper, H.A.4    Gastineau, D.A.5
  • 37
    • 84906101457 scopus 로고
    • Clinical effect of recombinant human activated factor VII (rVIIa NOVO)
    • 3 V008
    • Harrison JF, Fegan C, Dasani H, Bloom AL. Clinical effect of recombinant human activated factor VII (rVIIa NOVO). Br J Haematol 1991; 77: 3 V008.
    • (1991) Br J Haematol , vol.77
    • Harrison, J.F.1    Fegan, C.2    Dasani, H.3    Bloom, A.L.4
  • 39
    • 20144389671 scopus 로고    scopus 로고
    • Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry
    • Parameswaran R, Shapiro AD, Gill JC, Kessler CM. Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry. Haemophilia 2005; 11: 100-6.
    • (2005) Haemophilia , vol.11 , pp. 100-106
    • Parameswaran, R.1    Shapiro, A.D.2    Gill, J.C.3    Kessler, C.M.4
  • 40
    • 0024351484 scopus 로고
    • Clinical experience with human plasma-derived factor VIIa in patients with hemophilia A and high titer inhibitors
    • Hedner U, Bjoern S, Bernvil SS, Tengborn L, Stigendahl L. Clinical experience with human plasma-derived factor VIIa in patients with hemophilia A and high titer inhibitors. Haemostasis 1989; 19: 335-43.
    • (1989) Haemostasis , vol.19 , pp. 335-343
    • Hedner, U.1    Bjoern, S.2    Bernvil, S.S.3    Tengborn, L.4    Stigendahl, L.5
  • 43
    • 79955406987 scopus 로고    scopus 로고
    • Off-label use of recombinant factor VIIa in US hospitals: analysis of hospital records
    • Logan AC, Yank V, Stafford RS. Off-label use of recombinant factor VIIa in US hospitals: analysis of hospital records. Ann Intern Med 2011; 154: 516-22.
    • (2011) Ann Intern Med , vol.154 , pp. 516-522
    • Logan, A.C.1    Yank, V.2    Stafford, R.S.3
  • 45
    • 52949108398 scopus 로고    scopus 로고
    • Single-dose recombinant activated factor VII for the treatment of joint bleeds in hemophilia patients with inhibitors
    • Shapiro AD. Single-dose recombinant activated factor VII for the treatment of joint bleeds in hemophilia patients with inhibitors. Clin Adv Hematol Oncol 2008; 6: 579-86.
    • (2008) Clin Adv Hematol Oncol , vol.6 , pp. 579-586
    • Shapiro, A.D.1
  • 46
    • 0242494903 scopus 로고    scopus 로고
    • Improved hemostasis with superactive analogs of factor VIIa in a mouse model of hemophilia A
    • Tranholm M, Kristensen K, Kristensen AT, Pyke C, Rojkjaer R, Persson E. Improved hemostasis with superactive analogs of factor VIIa in a mouse model of hemophilia A. Blood 2003; 102: 3615-20.
    • (2003) Blood , vol.102 , pp. 3615-3620
    • Tranholm, M.1    Kristensen, K.2    Kristensen, A.T.3    Pyke, C.4    Rojkjaer, R.5    Persson, E.6
  • 48
    • 84897521879 scopus 로고    scopus 로고
    • FVIIa as used pharmacologically is not TF dependent in hemophilia B mice
    • Feng D, Whinna H, Monroe D, Stafford DW. FVIIa as used pharmacologically is not TF dependent in hemophilia B mice. Blood 2014; 123: 1764-6.
    • (2014) Blood , vol.123 , pp. 1764-1766
    • Feng, D.1    Whinna, H.2    Monroe, D.3    Stafford, D.W.4
  • 49
    • 0022531817 scopus 로고
    • Factor VII binding to tissue factor in reconstituted phospholipid vesicles: induction of cooperativity by phosphatidylserine
    • Bach R, Gentry R, Nemerson Y. Factor VII binding to tissue factor in reconstituted phospholipid vesicles: induction of cooperativity by phosphatidylserine. Biochemistry 1986; 25: 4007-20.
    • (1986) Biochemistry , vol.25 , pp. 4007-4020
    • Bach, R.1    Gentry, R.2    Nemerson, Y.3


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