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Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (\<) 24 months of age.
Official title: A Phase 3, Open-label Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age
Key Details
Gender
All
Age Range
12 Months - 24 Months
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2023-06-27
Completion Date
2025-09-04
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
ELX/TEZ/IVA
Fixed-dose combination granules for oral administration.
IVA
Granules for oral administration
Locations (19)
Telethon Kids Institute
Nedlands, Australia
The Royal Children's Hospital
Parkville, Australia
Queensland Children's Hospital
South Brisbane, Australia
The Children's Hospital at Westmead
Westmead, Australia
The Hospital for Sick Children
Toronto, Canada
British Columbia Children's Hospital
Vancouver, Canada
Juliane Marie Center, Rigshospitalet
Copenhagen, Denmark
Charite Paediatric Pulmonology Department
Berlin, Germany
Kinderklinik III, Abt. fur Pneumologie
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Erasmus Medical Center / Sophia Children's Hospital
Rotterdam, Netherlands
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Kinderspital Zuerich
Zurich, Switzerland
Children and Young Adults Research Unit
Cardiff, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom