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

Research output: Contribution to journalArticle

66 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)869-880
Number of pages12
JournalHaemophilia
Volume15
Issue number4
DOIs
StatePublished - 2009

Fingerprint

Factor VIII
Hemophilia A
Pharmacokinetics
Safety
Affinity Chromatography
Albumins
Therapeutics
Cell Culture Techniques
Monoclonal Antibodies
Ligands
recombinant factor VIII SQ
B-domain-deleted factor VIII

Keywords

  • BDDrFVIII
  • Factor VIII
  • Haemophilia
  • Pharmacokinetics

ASJC Scopus subject areas

  • Hematology
  • Genetics(clinical)

Cite this

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 journalArticle

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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