CFDB - Cystic Fibrosis DataBase

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ongoing trials trial from other registries

A Phase 3 Open-label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older

  • Year: 2024
  • Date: new
  • Author:
Participants

3 patients 0-17 years with Cystic Fibrosis

Interventions

VX-445/VX-661/VX-770 fixed-dose combination granules, VX-445/VX-661/VX-770 fixed-dose combination granules, VX-770 granules, Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets, Kalydeco 150 mg film-coated tablets, VX-770 75mg, Kaftrio 75 mg/50 mg/100 mg film-coated tablets, Kalydeco 75 mg film-coated tablets, Kalydeco 75 mg granules in sachet

Outcome measures

Safety and tolerability of ELX/TEZ/IVA based on adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Keywords: CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-770; VX-661; ivacaftor; Aminophenols; tezacaftor; VX-445; elexacaftor; Trikafta;