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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

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

    • Most Recent Events

    • 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 (CF) 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/ivacafto
    • 01 Nov 2018 Based on the data of EVOLVE and EXPAND studies, the European Commission has granted Marketing Authorization for SYMKEVI in a combination regimen with ivacaftor for the treatment of people with cystic fibrosis aged 12 and older who either have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, or one copy of the F508del mutation and a copy of the 14 mutations in which the CFTR protein shows residual activity.
    • 18 Oct 2018 According to a Vertex Pharmaceuticals media release, data were presented at at North American Cystic Fibrosis Conference (NACFC).

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