A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

Trial Profile

A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2017

At a glance

  • Drugs Lonoctocog alfa (Primary)
  • 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, data from AFFINITY clinical development program were published in the American Society of Hematology's publication Blood.
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