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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
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.
Age
1 - 11 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 21, 2022
Primary Completion Date
June 30, 2030
Completion Date
June 30, 2030
Last Updated
November 6, 2025
210
ESTIMATED participants
VX-121/TEZ/D-IVA
DRUG
Lead Sponsor
Vertex Pharmaceuticals Incorporated
NCT02417740
NCT06616857
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07108153