An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

Trial Profile

An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Migalastat (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 15 Sep 2017 This trial has been completed in Denmark.
    • 14 Sep 2017 According to an Amicus Therapeutics media release, based on the clinical data from two Phase 3 pivotal studies in both treatment naive (FACETS) and enzyme replacement therapy switch patients (ATTRACT), as well as an ongoing long-term extension study and overall body of evidence, Health Canada has approved the oral precision medicine Galafold for long-term treatment of adults with a confirmed diagnosis of Fabry disease and who have an alpha-GalA mutation.
    • 24 Aug 2017 This trial was completed in Belgium, according to European Clinical Trials Database.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top