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Volumn 15, Issue 4, 2009, Pages 869-880

Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: Demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII

Author keywords

BDDrFVIII; Factor VIII; Haemophilia; Pharmacokinetics

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8;

EID: 67649855138     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2009.02027.x     Document Type: Article
Times cited : (86)

References (17)
  • 1
    • 33750220441 scopus 로고    scopus 로고
    • Should hemophilia treaters switch to albumin-free recombinant factor VIII concentrates
    • Meeks SL, Josephson CD. Should hemophilia treaters switch to albumin-free recombinant factor VIII concentrates. Curr Opin Hematol 2006; 13: 457-61.
    • (2006) Curr Opin Hematol , vol.13 , pp. 457-461
    • Meeks, S.L.1    Josephson, C.D.2
  • 2
    • 2442630404 scopus 로고    scopus 로고
    • Isolation of a peptide ligand for affinity purification of factor VIII using phage display
    • Kelley BD, Booth J, Tannatt M et al. Isolation of a peptide ligand for affinity purification of factor VIII using phage display. J Chromatogr A 2004; 1038: 121-30.
    • (2004) J Chromatogr A , vol.1038 , pp. 121-130
    • Kelley, B.D.1    Booth, J.2    Tannatt, M.3
  • 3
    • 4043069930 scopus 로고    scopus 로고
    • Development and validation of an affinity chromatography step using a peptide ligand for cGMP production of factor VIII
    • Kelley BD, Tannatt M, Magnusson R, Hagelberg S, Booth J. Development and validation of an affinity chromatography step using a peptide ligand for cGMP production of factor VIII. Biotechnol Bioeng 2004; 87: 400-12.
    • (2004) Biotechnol Bioeng , vol.87 , pp. 400-412
    • Kelley, B.D.1    Tannatt, M.2    Magnusson, R.3    Hagelberg, S.4    Booth, J.5
  • 4
    • 67649883319 scopus 로고    scopus 로고
    • Results of a single-dose, randomized, double-blind, 2-period crossover
    • Recht M, Abshire T, Lusher J et.al. Results of a single-dose, randomized, double-blind, 2-period crossover pharmacokinetic study of B-domain deleted recombinant FVIII (BDDrFVIII), current manufacturing process (ReFacto), and BDDrFVIII, albumin-free manufacturing process (ReFacto AF). Blood 2003: Poster Session 162-III; 102: 111.
    • (2003) , vol.102 , pp. 111
    • Recht, M.1    Abshire, T.2    Lusher, J.3
  • 6
    • 33846907893 scopus 로고    scopus 로고
    • ReFacto and Advate: A single-dose, randomized, two-period crossover pharmacokinetics study in subjects with haemophilia A
    • Di Paola J, Smith MP, Klamroth R et.al. ReFacto and Advate: A single-dose, randomized, two-period crossover pharmacokinetics study in subjects with haemophilia A. Haemophilia 2007; 13: 124-30.
    • (2007) Haemophilia , vol.13 , pp. 124-130
    • Di Paola, J.1    Smith, M.P.2    Klamroth, R.3
  • 8
    • 16344370554 scopus 로고    scopus 로고
    • B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: A randomized, three-way crossover study
    • Kessler C, Gill J, White G et.al. B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: A randomized, three-way crossover study. Haemophilia 2005; 11: 84-91.
    • (2005) Haemophilia , vol.11 , pp. 84-91
    • Kessler, C.1    Gill, J.2    White, G.3
  • 9
    • 0034964673 scopus 로고    scopus 로고
    • Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients
    • Courter S, Bedrosian C. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 2001; 38 (2 Suppl 4): 44-51.
    • (2001) Semin Hematol , vol.38 , Issue.2 SUPPL. 4 , pp. 44-51
    • Courter, S.1    Bedrosian, C.2
  • 10
    • 4944263724 scopus 로고    scopus 로고
    • Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: Pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A
    • Tarantino MD, Collins PW, Hay CRM et.al. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/ albumin-free method: Pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia 2004; 10: 428-37.
    • (2004) Haemophilia , vol.10 , pp. 428-437
    • Tarantino, M.D.1    Collins, P.W.2    Hay, C.R.M.3
  • 11
    • 13844276825 scopus 로고    scopus 로고
    • A Bayesian approach to the assessment of inhibitor risk in studies of factor VIII concentrates
    • Lee M, Roth D. A Bayesian approach to the assessment of inhibitor risk in studies of factor VIII concentrates. Haemophilia 2005; 11: 5-12.
    • (2005) Haemophilia , vol.11 , pp. 5-12
    • Lee, M.1    Roth, D.2
  • 12
    • 0037276262 scopus 로고    scopus 로고
    • The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A
    • Lusher JM, Lee CA, Kessler CM, Bedrosian CL. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A. Haemophilia 2003; 9: 38-49.
    • (2003) Haemophilia , vol.9 , pp. 38-49
    • Lusher, J.M.1    Lee, C.A.2    Kessler, C.M.3    Bedrosian, C.L.4
  • 14
    • 51249107088 scopus 로고    scopus 로고
    • Effects of secondary prophylaxis started in adolescent and adult haemophiliacs
    • Tagliaferri A, Franchini M, Coppola A et al. Effects of secondary prophylaxis started in adolescent and adult haemophiliacs. Haemophilia 2008; 14: 945-951.
    • (2008) Haemophilia , vol.14 , pp. 945-951
    • Tagliaferri, A.1    Franchini, M.2    Coppola, A.3
  • 15
    • 1842336791 scopus 로고    scopus 로고
    • A multicenter phamacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A
    • Ayugoren-Pursun E, Scharrer I, Group GKS. A multicenter phamacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A. Thromb Haemost 1997; 78: 1352-6.
    • (1997) Thromb Haemost , vol.78 , pp. 1352-1356
    • Ayugoren-Pursun, E.1    Scharrer, I.2
  • 16
    • 6644228391 scopus 로고    scopus 로고
    • Safety and efficacy of a new recombinant FVIII formulated with sucrose (rFVIIII-FS) in patients with hemophilia A: A long-term, multicentre clinical study in Japan
    • Yoshioka A, Shima M, Fukutake K, Takamatsu J, Shirahata A. Safety and efficacy of a new recombinant FVIII formulated with sucrose (rFVIIII-FS) in patients with hemophilia A: A long-term, multicentre clinical study in Japan. Haemophilia 2001; 7: 242-9.
    • (2001) Haemophilia , vol.7 , pp. 242-249
    • Yoshioka, A.1    Shima, M.2    Fukutake, K.3    Takamatsu, J.4    Shirahata, A.5
  • 17
    • 0030942094 scopus 로고    scopus 로고
    • A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A
    • The Recombinate Previously Treated Patient Study Group
    • White GC, Courter S, Bray G, Lee M, Gomperts E. A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A. The Recombinate Previously Treated Patient Study Group. Thromb Haemost 1997; 77: 660-7.
    • (1997) Thromb Haemost , vol.77 , pp. 660-667
    • White, G.C.1    Courter, S.2    Bray, G.3    Lee, M.4    Gomperts, E.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.