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A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

Trial Profile

A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2019

At a glance

  • Drugs ATB 200 (Primary) ; Miglustat (Primary) ; Alglucosidase alfa
  • Indications Glycogen storage disease type II
  • Focus Registrational; Therapeutic Use
  • Acronyms PROPEL
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 08 Feb 2019 Planned number of patients changed to 110.
    • 07 Jan 2019 According to an Amicus Therapeutics media release, 1000L scale material has been released for the study and the company expects to complete enrollment in the study in 2019.
    • 20 Dec 2018 According to an Amicus Therapeutics media release, based on regulatory feedback from both the U.S. FDA and European Medicines Agency (EMA), the PROPEL study is expected to support approval for a broad indication, including ERT switch patients and treatment naive, as well as the pediatric population.
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