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A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age

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Trial Profile

A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Elexacaftor/ivacaftor/tezacaftor (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Vertex Pharmaceuticals

    • Most Recent Events

    • 28 Feb 2025 According to a Vertex Pharmaceuticals media release, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for the treatment of people with cystic fibrosis (CF) aged 2 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
    • 05 Feb 2024 Results presented in a Vertex Pharmaceuticals Media Release.
    • 18 May 2022 Results by deriving clinical efficacy inputs were derived from NCT03691779, NCT03525444; estimating survival in Brazilian F/MF pwCF aged 6 years receiving ELX/TEZ/IVA+best supportive care (BSC) versus BSC-alone, presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research

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