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: 28 Sep 2017

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

    • 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.
    • 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.
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