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A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation

Trial Profile

A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation

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

Latest Information Update: 16 May 2019

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At a glance

  • Drugs Ivacaftor/tezacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Registrational
  • Acronyms EXTEND
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 28 Feb 2019 Status changed from recruiting to active, no longer recruiting.
    • 07 Jun 2018 According to the Vertex Pharmaceuticals media release, interim analysis data from this study were presented at the 41st European Cystic Fibrosis Conference 2018.
    • 27 Apr 2018 New trial record
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