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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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2019

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At a glance

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

    • 11 Nov 2019 According to an Amicus Therapeutics media release, this study is expected to enroll approximately 120 patients by year-end 2019.
    • 08 Aug 2019 According to an Amicus Therapeutics media release, the study is n track to achieve full enrollment of ~100 patients by year-end 2019. The study is now more than a majority enrolled.
    • 26 Apr 2019 Planned primary completion date changed from 1 Oct 2020 to 1 Dec 2020.
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