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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

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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: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2022

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At a glance

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

    • Most Recent Events

    • 10 Jun 2022 According to a Vertex media release, data from this study will be presented at 45th European Cystic Fibrosis Conference.
    • 08 Nov 2021 Status changed from active, no longer recruiting to completed.
    • 05 Nov 2021 This trial has been completed in Germany (Global end date: 7 Oct 2021).
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