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 in Cystic Fibrosis Subjects 12 Months of Age and Older

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

15 patients 0-17 years with Cystic Fibrosis

Interventions

VX-770 50mg, VX-770 granules, Kalydeco 75 mg granules in sachet, VX-445/VX-661/VX-770 granules, VX-445/VX-661/VX-770 fixed-dose combination granules, Ivacaftor 25 mg granules, Kalydeco 59.5 mg granules in sachet, VX-770 75mg, Kaftrio 60 mg/40 mg/80 mg granules in sachet, Kalydeco 50 mg granules in sachet, Kaftrio 75 mg/50 mg/100 mg granules in sachet, VX-445/VX-661/VX-770 granules, Kalydeco 25 mg granules in sachet, VX-445/VX-661/VX-770 fixed-dose combination granules

Outcome measures

Safety and tolerability assessments as determined by 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;