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A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Trial Profile

A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jun 2019

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At a glance

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

    • 21 Jun 2019 According to a Vertex Pharmaceuticals media release, An additional dosage strength of SYMDEKO tablets is now available (tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval.
    • 21 Jun 2019 According to a Vertex Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to SYMDEKO.
    • 18 Apr 2019 This trial has been completed in Poland, according to European Clinical Trials Database.
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