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Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A.

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  • Additional Information
    • Source:
      Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE
    • Publication Information:
      Original Publication: Malden, MA : WileyBlackwell Pub., 2008-
    • Subject Terms:
      Coagulants/*pharmacokinetics ; Factor VIII/*pharmacokinetics ; Hemophilia A/*drug therapy; Adolescent ; Adult ; Aged ; Biological Availability ; Blood Coagulation Tests ; Coagulants/therapeutic use ; Cross-Over Studies ; Factor VIII/therapeutic use ; Hemophilia A/blood ; Humans ; Male ; Middle Aged ; Therapeutic Equivalency ; Treatment Outcome ; Young Adult
    • Abstract:
      An open-label, single-dose, randomized, two-period, crossover study comparing the pharmacokinetics of factor VIII activity in plasma (FVIII:C) after administration of an albumin-free presentation of moroctocog alfa (test) and moroctocog alfa manufactured using the previous technique (reference) was conducted in 30 (25 evaluable) male subjects who had severe hemophilia A (FVIII:C < 1 IU/dL). Blood samples were collected for 48 h after administration of each dose.
      Fviii: C was assayed using a chromogenic substrate assay. The FVIII:C pharmacokinetic parameters were calculated using noncompartmental analysis. The presentations would be bioequivalent if the 90% confidence limits of the ratio of the geometric mean values of AUC inf and recovery fell within the interval of 80-125%. The bioequivalence criteria were met. A total of 10 treatment-related adverse events were observed in a total of nine subjects. All were mild and none was determined to be related to administration of study medication.
      (© 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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    • Molecular Sequence:
      ClinicalTrials.gov NCT00038935
    • Accession Number:
      0 (Coagulants)
      113E3Z3CJJ (recombinant factor VIII SQ)
      9001-27-8 (Factor VIII)
    • Publication Date:
      Date Created: 20180326 Date Completed: 20190503 Latest Revision: 20190503
    • Publication Date:
      20250114
    • Accession Number:
      PMC5944578
    • Accession Number:
      10.1111/cts.12544
    • Accession Number:
      29575770