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

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2017

At a glance

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

    • 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.
    • 09 Jan 2017 According to a CSL Behring media release, AFSTYLA has been approved by the European Commision for the treatment of adults and children with hemophilia A. The approval was based on results from AFFINITY clinical development program.
    • 14 Dec 2016 According to a CSL Behring media release, data comparing the pharmacokinetics of AFSTYLA and octocog alfa in patients with severe haemophilia A were recently published in The World Federation of Hemophilia's journal Haemophilia.
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