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

Keywords

  • BDDrFVIII
  • Factor VIII
  • Haemophilia
  • Pharmacokinetics

ASJC Scopus subject areas

  • Hematology
  • Genetics(clinical)

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