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A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 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 VX-661 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: 20 Jan 2022

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At a glance

  • Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EVOLVE
  • Sponsors Vertex Pharmaceuticals

    • Most Recent Events

    • 23 Sep 2021 Results deriving results from NCT02347657 and other study; developing a prediction model and projecting the impact of introducing ELEX/TEZ/IVA on this outcome measure, published in the Thorax
    • 20 May 2021 Outcomes of a validated, lifetime, patient-level simulation model build using data from the IVA/TEZ/ELX Phase 3b study (NCT04105972) and TEZ/IVA Phase 3 study (NCT02347657), were presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
    • 12 Mar 2019 According to a Vertex Pharmaceuticals media release, based on the data from EVOLVE and EXPAND studies, the Therapeutic Goods Administration (TGA) of Australia has granted registration to SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor.
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