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
- 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.