메뉴 건너뛰기




Volumn 16, Issue 2, 2010, Pages 240-246

An open clinical study assessing the efficacy and safety of Factor IX Grifols®, a high-purity Factor IX concentrate, in patients with severe haemophilia B

Author keywords

Efficacy; Factor IX; Factor IX Grifols ; Grifols; Haemophilia; Haemophilia B

Indexed keywords

BLOOD CLOTTING FACTOR 9 CONCENTRATE; GRIFOLS; UNCLASSIFIED DRUG;

EID: 77950191134     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2009.02090.x     Document Type: Review
Times cited : (12)

References (23)
  • 1
    • 85047696213 scopus 로고
    • The need for highly purified products to treat hemophilia B
    • Scharrer I. The need for highly purified products to treat hemophilia B. Acta Haematol 1995, 94:2-7.
    • (1995) Acta Haematol , vol.94 , pp. 2-7
    • Scharrer, I.1
  • 2
    • 0344131428 scopus 로고    scopus 로고
    • Thrombogenicity of prothrombin complex concentrates
    • Kohler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res 1999, 95:S13-7.
    • (1999) Thromb Res , vol.95
    • Kohler, M.1
  • 3
    • 0026501455 scopus 로고
    • Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates
    • Kim HC, McMillan CW, White GC, Bergman GE, Horton MW, Saidi P. Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates. Blood 1992, 79:568-75.
    • (1992) Blood , vol.79 , pp. 568-575
    • Kim, H.C.1    McMillan, C.W.2    White, G.C.3    Bergman, G.E.4    Horton, M.W.5    Saidi, P.6
  • 4
    • 17144451305 scopus 로고    scopus 로고
    • A cross-over pharmacokinetic study of a double viral inactivated factor IX concentrate (15 nm filtration and SD) compared to a SD factor IX concentrate
    • Goudemand J, Peynet J, Chambost H. A cross-over pharmacokinetic study of a double viral inactivated factor IX concentrate (15 nm filtration and SD) compared to a SD factor IX concentrate. Thromb Haemost 1998, 80:919-24.
    • (1998) Thromb Haemost , vol.80 , pp. 919-924
    • Goudemand, J.1    Peynet, J.2    Chambost, H.3
  • 5
    • 0032932329 scopus 로고    scopus 로고
    • Efficacy of a high purity, chemically treated and nanofiltered factor IX concentrate for continuous infusion in haemophilia 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 haemophilia 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
  • 6
    • 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
  • 7
    • 15444379559 scopus 로고    scopus 로고
    • Product selection issues in the management of hemophilia B
    • Di Paola J. Product selection issues in the management of hemophilia B. Blood Coagul Fibrinolysis 2004, 15:S17-8.
    • (2004) Blood Coagul Fibrinolysis , vol.15
    • Di Paola, J.1
  • 8
    • 0033935277 scopus 로고    scopus 로고
    • Inhibitor antibodies to factor VIII and factor IX: management
    • Lusher JM. Inhibitor antibodies to factor VIII and factor IX: management. Semin Thromb Hemost 2000, 26:179-88.
    • (2000) Semin Thromb Hemost , vol.26 , pp. 179-188
    • Lusher, J.M.1
  • 9
    • 0031727621 scopus 로고    scopus 로고
    • Development of anaphylactic shock in haemophilia B patients with inhibitors
    • Warrier I, Lusher JM. Development of anaphylactic shock in haemophilia B patients with inhibitors. Blood Coagul Fibrinolysis 1998, 9:S125-8.
    • (1998) Blood Coagul Fibrinolysis , vol.9
    • Warrier, I.1    Lusher, J.M.2
  • 11
    • 6544277992 scopus 로고    scopus 로고
    • Anaphylactic response to factor IX replacement therapy in haemophilia B patients: complete gene deletions confer the highest risk
    • Thorland EC, Drost JB, Lusher JM. Anaphylactic response to factor IX replacement therapy in haemophilia B patients: complete gene deletions confer the highest risk. Haemophilia 1999, 5:101-5.
    • (1999) Haemophilia , vol.5 , pp. 101-105
    • Thorland, E.C.1    Drost, J.B.2    Lusher, J.M.3
  • 12
    • 13844295682 scopus 로고    scopus 로고
    • Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products (CPMP/BPWG/198/95 rev. 1)
    • London, October 19th
    • Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products (CPMP/BPWG/198/95 rev. 1). 2000, London, October 19th
    • (2000)
  • 13
    • 43949091717 scopus 로고    scopus 로고
    • Core SPC for human plasma derived and recombinant coagulation factor IX products (CPMP/BPWG/1625/99)
    • London, June 29th
    • Core SPC for human plasma derived and recombinant coagulation factor IX products (CPMP/BPWG/1625/99). 2000, London, June 29th
    • (2000)
  • 14
    • 33947444499 scopus 로고
    • Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids
    • Cohn EJ, Strong LE, Hughes WL. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946, 68:459-75.
    • (1946) J Am Chem Soc , vol.68 , pp. 459-475
    • Cohn, E.J.1    Strong, L.E.2    Hughes, W.L.3
  • 15
    • 0001487508 scopus 로고
    • A system for the separation of the components of human blood: quantitative procedures for the separation of the protein components of human plasma
    • Cohn EJ, Gurd FRN, Surgenor DM. A system for the separation of the components of human blood: quantitative procedures for the separation of the protein components of human plasma. J Am Chem Soc 1950, 72:465-74.
    • (1950) J Am Chem Soc , vol.72 , pp. 465-474
    • Cohn, E.J.1    Gurd, F.R.N.2    Surgenor, D.M.3
  • 17
    • 0006021049 scopus 로고    scopus 로고
    • Coagulation testing: part 1, current methods and challenges
    • Carville DGM, Guyer KE. Coagulation testing: part 1, current methods and challenges. IVD Tech 1998, 4:59-66.
    • (1998) IVD Tech , vol.4 , pp. 59-66
    • Carville, D.G.M.1    Guyer, K.E.2
  • 19
    • 0020741664 scopus 로고
    • If nothing goes wrong, is everything all right? Interpreting zero numerators
    • Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983, 249:1743-5.
    • (1983) JAMA , vol.249 , pp. 1743-1745
    • Hanley, J.A.1    Lippman-Hand, A.2
  • 20
    • 19944429262 scopus 로고    scopus 로고
    • The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B
    • Shapiro AD, Di Paola J, Cohen A. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood 2005, 105:518-25.
    • (2005) Blood , vol.105 , pp. 518-525
    • Shapiro, A.D.1    Di Paola, J.2    Cohen, A.3
  • 21
    • 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. 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
  • 22
    • 0037279116 scopus 로고    scopus 로고
    • Guidelines on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders
    • Guidelines on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. Haemophilia 2003, 9:1-23.
    • (2003) Haemophilia , vol.9 , pp. 1-23
  • 23
    • 0029151126 scopus 로고
    • High-purity factor IX concentrates for treatment of hemophilia B: relative purity and thrombogenic potential
    • Limentani SA, Gowell KP, Deitcher SR. High-purity factor IX concentrates for treatment of hemophilia B: relative purity and thrombogenic potential. Acta Haematol 1995, 94:12-7.
    • (1995) Acta Haematol , vol.94 , pp. 12-17
    • Limentani, S.A.1    Gowell, K.P.2    Deitcher, S.R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.