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An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

Trial Profile

An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Sep 2019

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At a glance

  • Drugs Ivacaftor/lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 11 Sep 2019 Planned End Date changed from 27 May 2020 to 1 Oct 2021.
    • 11 Sep 2019 Planned primary completion date changed from 1 Jun 2020 to 1 Nov 2020.
    • 16 Aug 2018 Status changed from not yet recruiting to recruiting.
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