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Phase 3B Open-Label Extension Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With GNE Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

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Trial Profile

Phase 3B Open-Label Extension Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With GNE Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2022

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At a glance

  • Drugs Aceneuramic acid (Primary)
  • Indications Nonaka distal myopathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical

Most Recent Events

  • 13 Feb 2019 New trial focus therapeutics use and new primary end point has been added.
  • 01 Jun 2018 Status changed from active, no longer recruiting to discontinued.
  • 28 Jan 2018 The study has been discontinued in Bulgaria.

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