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A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

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Trial Profile

A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2025

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At a glance

  • Drugs Elexacaftor/ivacaftor/tezacaftor (Primary) ; Ivacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Registrational
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 15 Apr 2025 Planned End Date changed from 1 Apr 2027 to 6 Apr 2027.
  • 15 Apr 2025 Planned primary completion date changed from 1 Apr 2027 to 6 Apr 2027.
  • 25 Sep 2024 This trial is ongoing in Belgium according to European Clinical Trials Database record.

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