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: 31 Jul 2017

At a glance

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