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ongoing trials trial from other registries

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation - Phase 3 - Not yet recruiting

  • Year: 2022
  • Date:
  • Author: Vertex Pharmaceuticals Incorporated
Source

https://ClinicalTrials.gov/show/NCT05274269

Study design (if review, criteria of inclusion for studies)

Controlled: Yes.1 Randomised: Yes.2 Open: No.3 Single blind: No.4 Double blind: Yes.5 Parallel group: No.6 Cross over: No

Participants

Subjects (male or female) 6 years of age and older with stable CF disease, FEV1 value >40% and <90% of predicted

Interventions

The efficacy and pharmacodynamics (PD) of ELX/TEZ/IVA

Outcome measures

Primary end point(s): Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) through Week 24

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