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An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)

Trial Profile

An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2018

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At a glance

  • Drugs Ataluren (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Registrational
  • Sponsors PTC Therapeutics
  • Most Recent Events

    • 30 May 2017 Planned End Date changed from 1 Jun 2019 to 1 May 2017.
    • 30 May 2017 Planned primary completion date changed from 1 Jun 2019 to 1 May 2017.
    • 02 Mar 2017 According to a PTC Therapeutics media release, based on the resuts from ACT CF trial (CTP 700244666), company plans to discontinue current clinical development of ataluren in cystic fibrosis, close ongoing extension studies and withdraw its application for marketing authorization in cystic fibrosis in Europe.
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