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A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Trial Profile

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2023

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At a glance

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

    • 09 Nov 2023 144-Week Interim Results From a 192-Week Open-label Extension Study assess long-term safety and efficacy of ELX/TEZ/IVA in these patients published in the European Respiratory Journal
    • 18 Jun 2021 According to a Vertex Pharmaceuticals media release, Health Canada has granted Marketing Authorization for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.This approval was supported by positive results of three global Phase 3 studies (Study 445-102, Study 445-103)
    • 24 Sep 2020 According to a Vertex Pharmaceuticals media release, data from this study will be presented at the 43rd European Cystic Fibrosis Digital Conference (ECFS) held September 24-25, 2020 and the 2020 North American Cystic Fibrosis Virtual Conference (NACFC) taking place October 7-23, 2020.
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