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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Official title: 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
Key Details
Gender
All
Age Range
12 Months - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-11-21
Completion Date
2027-09-30
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
ELX/TEZ/IVA
Fixed-dose combination granules for oral administration.
IVA
Granules for oral administration
Locations (18)
The Kids Research Institute Australia
Nedlands, Australia
The Royal Children's Hospital
Parkville, Australia
Queensland Children's Hospital
South Brisbane, Australia
The Hospital for Sick Children
Toronto, Canada
British Columbia Children's Hospital
Vancouver, Canada
Juliane Marie Center, Rigshospitalet
Copenhagen, Denmark
Charité Universitätsmedizin BerlinX
Berlin, Germany
Kinderklinik III, Abt. fur Pneumologie
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Erasmus Medical Center
Rotterdam, Netherlands
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Kinderspital Zurich
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