메뉴 건너뛰기




Volumn 17, Issue 4, 2011, Pages 590-596

A clinical study assessing the pharmacokinetics, efficacy and safety of AlphaNine ®, a high-purity factor IX concentrate, in patients with severe haemophilia B

Author keywords

AlphaNine ; Efficacy; Factor IX; Haemophilia; Haemophilia B; Pharmacokinetics

Indexed keywords

ALANINE AMINOTRANSFERASE; BLOOD CLOTTING FACTOR 9 CONCENTRATE;

EID: 79959499738     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2010.02470.x     Document Type: Article
Times cited : (20)

References (31)
  • 1
  • 2
    • 79959503697 scopus 로고    scopus 로고
    • Hemophilia B Mutation database. database of point. Last accessed: March 15, 2010.
    • Hemophilia B Mutation database. database of point. Last accessed: March 15, 2010.
  • 3
    • 0027123107 scopus 로고
    • Molecular and cellular biology of blood coagulation
    • Furie B, Furie BC. Molecular and cellular biology of blood coagulation. N Engl J Med 1992; 326: 800-6.
    • (1992) N Engl J Med , vol.326 , pp. 800-806
    • Furie, B.1    Furie, B.C.2
  • 5
    • 0027502870 scopus 로고
    • PACE/furin can process the vitamin K-dependent pro-factor IX precursor within the secretory pathway
    • Wasley LC, Rehemtulla A, Bristol JA et al. PACE/furin can process the vitamin K-dependent pro-factor IX precursor within the secretory pathway. J Biol Chem 1993; 268: 8458-65.
    • (1993) J Biol Chem , vol.268 , pp. 8458-8465
    • Wasley, L.C.1    Rehemtulla, A.2    Bristol, J.A.3
  • 6
    • 33646126521 scopus 로고    scopus 로고
    • Pathogenesis of hemophilic arthropathy
    • Roosendal G, Lafeber FP. Pathogenesis of hemophilic arthropathy. Haemophilia 2006; 12(Suppl. 3): 117-21.
    • (2006) Haemophilia , vol.12 , Issue.SUPPL. 3 , pp. 117-121
    • Roosendal, G.1    Lafeber, F.P.2
  • 7
    • 0026727246 scopus 로고
    • Update of 156 episodes of central nervous system in hemophiliacs
    • de Tezanos Pinto M, Fernandez J, Perez Bianco PR. Update of 156 episodes of central nervous system in hemophiliacs. Hemostasis 1992; 22: 259-67.
    • (1992) Hemostasis , vol.22 , pp. 259-267
    • de Tezanos Pinto, M.1    Fernandez, J.2    Perez Bianco, P.R.3
  • 8
    • 0025871337 scopus 로고
    • Monoclonal antibody-purified factor IX-comparative thrombogenicity to prothrombin complex concentrate
    • Kim HC, Matts L, Eisele J, Czachur M, Saidi P. Monoclonal antibody-purified factor IX-comparative thrombogenicity to prothrombin complex concentrate. Semin Hematol 1991; 28(Suppl. 6): 15-9.
    • (1991) Semin Hematol , vol.28 , Issue.SUPPL. 6 , pp. 15-19
    • Kim, H.C.1    Matts, L.2    Eisele, J.3    Czachur, M.4    Saidi, P.5
  • 9
    • 0035669048 scopus 로고    scopus 로고
    • Factor IX and thrombosis
    • Lowe GD. Factor IX and thrombosis. Br J Hematol 2001; 115: 507-13.
    • (2001) Br J Hematol , vol.115 , pp. 507-513
    • Lowe, G.D.1
  • 10
    • 0344131428 scopus 로고    scopus 로고
    • Thrombogenicity of prothrombin complex concentrates
    • Köhler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res 1999; 95(Suppl. 1): S13-7.
    • (1999) Thromb Res , vol.95 , Issue.SUPPL. 1
    • Köhler, M.1
  • 11
    • 0032932329 scopus 로고    scopus 로고
    • Efficacy of a high purity, chemically treated and nanofiltered factor IX concentrate for continuous infusion in hemophilia patients undergoing surgery
    • Schulman S, Wallensten R, White B, Smith OP. Efficacy of a high purity, chemically treated and nanofiltered factor IX concentrate for continuous infusion in hemophilia patients undergoing surgery. Haemophilia 1999; 5: 96-100.
    • (1999) Haemophilia , vol.5 , pp. 96-100
    • Schulman, S.1    Wallensten, R.2    White, B.3    Smith, O.P.4
  • 12
    • 79959494959 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products (EMEA). Note for Guidance on the clinical investigation of human plasma derived factor VIII and IX products (CPMP/BPWP/198/95 rev.1), London, October 19th, 2000.
    • The European Agency for the Evaluation of Medicinal Products (EMEA). Note for Guidance on the clinical investigation of human plasma derived factor VIII and IX products (CPMP/BPWP/198/95 rev.1), London, October 19th, 2000.
  • 13
    • 79959519222 scopus 로고    scopus 로고
    • the factor VIII/factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Hemostasis Scientific and Standardization Committee communication. The Design and Analysis of Pharmacokinetic Studies of Coagulation factors. Posted on ISTH Website 21 March, 2001. Available at .
    • Lee M, Morfini M, Schulman S, Ingerslev J and the factor VIII/factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Hemostasis Scientific and Standardization Committee communication. The Design and Analysis of Pharmacokinetic Studies of Coagulation factors. Posted on ISTH Website 21 March, 2001. Available at .
    • Lee, M.1    Morfini, M.2    Schulman, S.3    Ingerslev, J.4
  • 14
    • 0035189391 scopus 로고    scopus 로고
    • Pharmacokinetics of coagulation factors: clinical relevance for patients with hemophilia
    • Bjorkman S, Berntorp E. Pharmacokinetics of coagulation factors: clinical relevance for patients with hemophilia. Clin Pharmacokinet 2001; 40: 815-32.
    • (2001) Clin Pharmacokinet , vol.40 , pp. 815-832
    • Bjorkman, S.1    Berntorp, E.2
  • 15
    • 47649125876 scopus 로고    scopus 로고
    • Factor IX pharmacokinetics: differences between plasma-derived and recombinant products and the clinical and economic implications: a meeting report
    • Morfini M, Laguna P, Leissinger C. Factor IX pharmacokinetics: differences between plasma-derived and recombinant products and the clinical and economic implications: a meeting report. Haemophilia 2008; 14: 873-5.
    • (2008) Haemophilia , vol.14 , pp. 873-875
    • Morfini, M.1    Laguna, P.2    Leissinger, C.3
  • 16
    • 0001776145 scopus 로고    scopus 로고
    • Multidose pharmacokinetics of factor IX: implications for dosing in prophylaxis
    • Carlsson M, Björkman S, Berntorp E. Multidose pharmacokinetics of factor IX: implications for dosing in prophylaxis. Haemophilia 1998; 4: 83-8.
    • (1998) Haemophilia , vol.4 , pp. 83-88
    • Carlsson, M.1    Björkman, S.2    Berntorp, E.3
  • 17
    • 27744605148 scopus 로고    scopus 로고
    • Use of pharmacokinetics in the coagulation factor treatment of patients with hemophilia
    • Shapiro AD, Korth-Bradley J, Poon MC. Use of pharmacokinetics in the coagulation factor treatment of patients with hemophilia. Haemophilia 2005; 11: 571-82.
    • (2005) Haemophilia , vol.11 , pp. 571-582
    • Shapiro, A.D.1    Korth-Bradley, J.2    Poon, M.C.3
  • 18
    • 33845730827 scopus 로고    scopus 로고
    • In vivo recovery of factor VIII and factor IX: intra- and interindividual variance in a clinical setting
    • Björkman S, Folkesson A, Berntorp E. In vivo recovery of factor VIII and factor IX: intra- and interindividual variance in a clinical setting. Haemophilia 2007; 13: 2-8.
    • (2007) Haemophilia , vol.13 , pp. 2-8
    • Björkman, S.1    Folkesson, A.2    Berntorp, E.3
  • 19
    • 0037764676 scopus 로고    scopus 로고
    • Pharmacokinetics of factor VIII and factor IX
    • Morfini M. Pharmacokinetics of factor VIII and factor IX. Haemophilia 2003; 9(Suppl. 1): 94-9.
    • (2003) Haemophilia , vol.9 , Issue.SUPPL. 1 , pp. 94-99
    • Morfini, M.1
  • 20
    • 70449576005 scopus 로고    scopus 로고
    • Pharmacokinetic study of a high-purity factor IX concentrate (Factor IX Grifols) with a 6-month follow up in previously treated patients with severe hemophilia B
    • Aznar JA, Cabrera N, Matysiak M et al. Pharmacokinetic study of a high-purity factor IX concentrate (Factor IX Grifols) with a 6-month follow up in previously treated patients with severe hemophilia B. Haemophilia 2009; 15: 1243-8.
    • (2009) Haemophilia , vol.15 , pp. 1243-1248
    • Aznar, J.A.1    Cabrera, N.2    Matysiak, M.3
  • 22
    • 0036484156 scopus 로고    scopus 로고
    • Pharmacokinetic analysis of plasma-derived and recombinant FIX concentrates in previously treated patients with moderate or severe hemophilia B
    • Ewenstein BM, Joist JH, Shapiro AD et al. Pharmacokinetic analysis of plasma-derived and recombinant FIX concentrates in previously treated patients with moderate or severe hemophilia B. Transfusion 2002; 42: 190-7.
    • (2002) Transfusion , vol.42 , pp. 190-197
    • Ewenstein, B.M.1    Joist, J.H.2    Shapiro, A.D.3
  • 23
    • 0038825183 scopus 로고    scopus 로고
    • The pharmacokinetics of clotting factor therapy
    • Berntorp E, Björkman S. The pharmacokinetics of clotting factor therapy. Haemophilia 2003; 9: 353-9.
    • (2003) Haemophilia , vol.9 , pp. 353-359
    • Berntorp, E.1    Björkman, S.2
  • 24
    • 33748760910 scopus 로고    scopus 로고
    • Pharmacokinetics of factors IX, recombinant human activated factor VII and factor XIII
    • Poon MC. Pharmacokinetics of factors IX, recombinant human activated factor VII and factor XIII. Haemophilia 2006; 12(Suppl. 4): 61-9.
    • (2006) Haemophilia , vol.12 , Issue.SUPPL. 4 , pp. 61-69
    • Poon, M.C.1
  • 25
    • 0035895058 scopus 로고    scopus 로고
    • Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates
    • Roth DA, Kessler CM, Pasi KJ et al. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood 2001; 98: 3600-6.
    • (2001) Blood , vol.98 , pp. 3600-3606
    • Roth, D.A.1    Kessler, C.M.2    Pasi, K.J.3
  • 26
    • 34248532042 scopus 로고    scopus 로고
    • Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe hemophilia B
    • Lambert T, Recht M, Valentino LA et al. Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe hemophilia B. Haemophilia 2007; 13: 233-43.
    • (2007) Haemophilia , vol.13 , pp. 233-243
    • Lambert, T.1    Recht, M.2    Valentino, L.A.3
  • 27
    • 0029043733 scopus 로고
    • Variability of in vivo recovery of factor IX after infusion of monoclonal antibody purified factor IX concentrates in patients with hemophilia B
    • the Mononine Study group
    • White GC, Shapiro AD, Kurczynski EM, Kim HC, Bergman GE, the Mononine Study group. Variability of in vivo recovery of factor IX after infusion of monoclonal antibody purified factor IX concentrates in patients with hemophilia B. Thromb Hemost 1995; 73: 779-84.
    • (1995) Thromb Hemost , vol.73 , pp. 779-784
    • White, G.C.1    Shapiro, A.D.2    Kurczynski, E.M.3    Kim, H.C.4    Bergman, G.E.5
  • 28
    • 37149051201 scopus 로고    scopus 로고
    • Safety procedures of coagulation factors
    • Jorquera JI. Safety procedures of coagulation factors. Haemophilia 2007; 13: 41-6.
    • (2007) Haemophilia , vol.13 , pp. 41-46
    • Jorquera, J.I.1
  • 29
    • 4444277653 scopus 로고    scopus 로고
    • Removal of TSE agents from blood products
    • Foster PR. Removal of TSE agents from blood products. Vox Sang 2004; 87: S7-10.
    • (2004) Vox Sang , vol.87
    • Foster, P.R.1
  • 30
    • 33846700716 scopus 로고    scopus 로고
    • Current strategies to prevent transmission of prions by human plasma derivatives
    • Burnouf T, Padilla A. Current strategies to prevent transmission of prions by human plasma derivatives. Transfus Clin Biol 2006; 13: 320-8.
    • (2006) Transfus Clin Biol , vol.13 , pp. 320-328
    • Burnouf, T.1    Padilla, A.2
  • 31
    • 37149016356 scopus 로고    scopus 로고
    • Efficacy of plasma derivatives purification processes to eliminate an experimental TSE-model agent
    • Biescas H, Nieto S, Caballero S, Díez JM, Gajardo R, Jorquera JI. Efficacy of plasma derivatives purification processes to eliminate an experimental TSE-model agent. Haemophilia 2006; 12(Suppl. 2): 5.
    • (2006) Haemophilia , vol.12 , Issue.SUPPL. 2 , pp. 5
    • Biescas, H.1    Nieto, S.2    Caballero, S.3    Díez, J.M.4    Gajardo, R.5    Jorquera, J.I.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.