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A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population with Severe Hemophilia A

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Trial Profile

A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population with Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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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.
    • 06 Feb 2017 Results published in the Journal of Thrombosis and Haemostasis.

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