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A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

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Trial Profile

A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Ivacaftor (Primary) ; Ivacaftor/lumacaftor (Primary) ; Lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms TRAFFIC
  • Sponsors Vertex Pharmaceuticals

    • Most Recent Events

    • 09 Jun 2017 According to a Vertex Pharmaceuticals media release, post-hoc analysis data from TRAFFIC, TRANSPORT and PROGRESS studies were presented at the 40th European Cystic Fibrosis Society (ECFS) Conference.
    • 08 Mar 2016 According to a Vertex Pharmaceuticals media release, the Therapeutic Goods Administration (TGA) of Australia approved ORKAMBI 200/125 (lumacaftor 200mg and ivacaftor 125mg), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation.
    • 26 Jan 2016 According to a Vertex Pharmaceuticals media release, lumacaftor/ivacaftor (ORKAMBI) has been approved by Health Canada treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older with two copies of the F508del mutation.

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