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An Open-label Study of the Safety, Pharmacokinetics, Efficacy, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Pediatric Subjects Aged 0 to < 18 Years With Late-onset Pompe Disease

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Trial Profile

An Open-label Study of the Safety, Pharmacokinetics, Efficacy, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Pediatric Subjects Aged 0 to < 18 Years With Late-onset Pompe Disease

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2024

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At a glance

  • Drugs Cipaglucosidase alfa (Primary) ; Miglustat (Primary)
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions; Registrational
  • Sponsors Amicus Therapeutics

    • Most Recent Events

    • 19 Oct 2021 Planned End Date changed from 1 Sep 2021 to 1 Jun 2026.
    • 19 Oct 2021 Planned primary completion date changed from 1 Sep 2021 to 1 Jun 2026.
    • 03 Sep 2021 Planned number of patients changed from 14 to 22.

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