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ongoing trials trial from other registries

A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

  • Year: 2021
  • Date:
  • Author:
Source

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005914-33/DE/

Participants

Principal inclusion criteria: 1. Subject (or the subject’s legally appointed and authorized representative) will sign and date an informed consent form (ICF) and, when appropriate, an assent form.

Interventions

Elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA)

Outcome measures

Primary end point(s): Safety and tolerability based on AEs, clinical laboratory values, ECGs, vital signs, and pulse oximetry

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