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A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study

Trial Profile

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2019

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At a glance

  • Drugs Lonoctocog alfa (Primary) ; Octocog alfa
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms AFFINITY
  • Sponsors CSL Behring
  • Most Recent Events

    • 01 Jul 2019 According to a CSL Behring media release, data from this study will be presented at this year's International Society on Thrombosis and Haemostasis (ISTH) Congress (Melbourne, Australia, 6th-10th, July, 2019).
    • 28 Sep 2017 According to a CSL Behring media release, Japan's Ministry of Health, Labor and Welfare (MHLW) has approved AFSTYLA (lonoctocog alfa) for the treatment of patients with haemophilia A (congenital factor VIII deficiency). The approval was based on results from the AFFINITY clinical development program.
    • 19 Apr 2017 According to a CSL Behring media release, the Australian Therapeutic Goods Administration (TGA) has approved AFSTYLA [lonoctocog alfa] in patients with haemophilia A (congenital factor VIII deficiency) based on results from trials in the AFFINITY program.
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