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Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Official title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age
Key Details
Gender
All
Age Range
1 Year - 11 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2022-06-21
Completion Date
2030-06-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
VX-121/TEZ/D-IVA
Fixed-dose combination for oral administration.
Locations (38)
Children's Hospital of Orange County
Orange, California, United States
Stanford University Clinical and Translational Research Unit
Palo Alto, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
The Emory Clinic / Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine / St. Louis Children's Hospital
St Louis, Missouri, United States
Cohen Children's Medical Center
Lake Success, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital - Wallace Tower
Houston, Texas, United States
Vermont Lung Center
Colchester, Vermont, United States
American Family Childrens Hospital
Madison, Wisconsin, United States
The Kids Research Institute Australia
Nedlands, Australia
Women's and Children's Hospital
North Adelaide, 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
CHU Lyon - Hopital Femme Mere-Enfant
Bron, France
Hopital Necker, Enfants Malades
Paris, France
Charité - Paediatric Pulmonology Department
Berlin, Germany
Universitatsklinikum Essen
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Erasmus Medical Center / Sophia Children's Hospital
Rotterdam, Netherlands
Starship Children's Hospital
Grafton, New Zealand
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Karolinska University Hospital - Pulmonology
Stockholm, Sweden
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Kinderspital Zurich
Zurich, Switzerland
Children and Young Adults Research Unit
Cardiff, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom