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A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT

Trial Profile

A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2019

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At a glance

  • Drugs Migalastat (Primary) ; Enzyme replacements
  • Indications Fabry's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms ATTRACT
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 18 Jan 2019 According to an Amicus Therapeutics media release, results from this study (30 month and post hoc analysis) and open-label extension studies will be presented at at 15th Annual WORLDSymposium 2019.
    • 31 Aug 2018 Biomarkers information updated
    • 22 Mar 2018 Based on the data from FACETS and ATTRACT studies, Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the oral small molecule pharmacological chaperone Galafold capsules 123mg (migalastat) for treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.
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