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A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

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Trial Profile

A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2022

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At a glance

Most Recent Events

  • 11 Jul 2022 Primary endpoint (Absolute change in lung clearance index 2.5 (LCI2.5)) has been met according to the results published in the American Journal of Respiratory and Critical Care Medicine
  • 11 Jul 2022 Results assessing efficacy and safety of ELX/TEZ/IVA in children 6 through 11 years of age with CF heterozygous for F508del and a minimal function CFTR mutation (F/MF genotypes) published in the American Journal of Respiratory and Critical Care Medicine
  • 27 Oct 2021 According to a Vertex Pharmaceuticals media release, the Supplement to a New Drug Submission for TRIKAFTA has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 6-11 years. The company will also will also submit this indication in parallel to both the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en sante et en services sociaux (INESSS) in Quebec for Health Technology Assessments.

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