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

Michael Recht; L. Nemes; M. Matysiak; M. Manco-Johnson; J. Lusher; M. Smith; P. Mannucci; C. Hay; T. Abshire; A. O'Brien; B. Hayward; C. Udata; D. A. Roth; S. Arkin

doi:10.1111/j.1365-2516.2009.02027.x

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

Michael Recht, L. Nemes, M. Matysiak, M. Manco-Johnson, J. Lusher, M. Smith, P. Mannucci, C. Hay, T. Abshire, A. O'Brien, B. Hayward, C. Udata, D. A. Roth, S. Arkin

Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico

Research output: Contribution to journal › Article › peer-review

Abstract

BDDrFVIII is a B-domain deleted recombinant factor VIII (rFVIII) product for haemophilia A. Manufacture uniquely includes purification chromatography by synthetic-affinity ligand rather than murine-based monoclonal antibody, as well as an albumin-free cell culture process. BDDrFVIII was studied in 204 patients, including 62 subjects

Original language	English
Pages (from-to)	869-880
Number of pages	12
Journal	Haemophilia
Volume	15
Issue number	4
DOIs	https://doi.org/10.1111/j.1365-2516.2009.02027.x
Publication status	Published - 2009

Keywords

BDDrFVIII
Factor VIII
Haemophilia
Pharmacokinetics

ASJC Scopus subject areas

Hematology
Genetics(clinical)

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Recht, M., Nemes, L., Matysiak, M., Manco-Johnson, M., Lusher, J., Smith, M., Mannucci, P., Hay, C., Abshire, T., O'Brien, A., Hayward, B., Udata, C., Roth, D. A., & Arkin, S. (2009). 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. Haemophilia, 15(4), 869-880. https://doi.org/10.1111/j.1365-2516.2009.02027.x

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. / Recht, Michael; Nemes, L.; Matysiak, M.; Manco-Johnson, M.; Lusher, J.; Smith, M.; Mannucci, P.; Hay, C.; Abshire, T.; O'Brien, A.; Hayward, B.; Udata, C.; Roth, D. A.; Arkin, S.

In: Haemophilia, Vol. 15, No. 4, 2009, p. 869-880.

Research output: Contribution to journal › Article › peer-review

Recht, M, Nemes, L, Matysiak, M, Manco-Johnson, M, Lusher, J, Smith, M, Mannucci, P, Hay, C, Abshire, T, O'Brien, A, Hayward, B, Udata, C, Roth, DA & Arkin, S 2009, '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', Haemophilia, vol. 15, no. 4, pp. 869-880. https://doi.org/10.1111/j.1365-2516.2009.02027.x

Recht M, Nemes L, Matysiak M, Manco-Johnson M, Lusher J, Smith M et al. 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. Haemophilia. 2009;15(4):869-880. https://doi.org/10.1111/j.1365-2516.2009.02027.x

Recht, Michael ; Nemes, L. ; Matysiak, M. ; Manco-Johnson, M. ; Lusher, J. ; Smith, M. ; Mannucci, P. ; Hay, C. ; Abshire, T. ; O'Brien, A. ; Hayward, B. ; Udata, C. ; Roth, D. A. ; Arkin, S. / 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. In: Haemophilia. 2009 ; Vol. 15, No. 4. pp. 869-880.

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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

Abstract

Keywords

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