Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age (NCT05422222)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Orange County โ Orange, California
Age range: 1 Year to 11 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (38 Sites)
Showing the first 25 of 38 sites.
- Children's Hospital of Orange County โ Orange, California
- Stanford University Clinical and Translational Research Unit โ Palo Alto, California
- Children's Hospital of Colorado โ Aurora, Colorado
- The Emory Clinic / Children's Healthcare of Atlanta at Egleston โ Atlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of Chicago โ Chicago, Illinois
- Riley Hospital for Children at Indiana University Health โ Indianapolis, Indiana
- Boston Children's Hospital โ Boston, Massachusetts
- Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota โ Minneapolis, Minnesota
- The Children's Mercy Hospital โ Kansas City, Missouri
- Washington University School of Medicine / St. Louis Children's Hospital โ St Louis, Missouri
- Cohen Children's Medical Center โ Lake Success, New York
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center โ Cleveland, Ohio
- Nationwide Children's Hospital โ Columbus, Ohio
- Oregon Health & Science University โ Portland, Oregon
- UPMC Children's Hospital of Pittsburgh โ Pittsburgh, Pennsylvania
- Texas Children's Hospital - Wallace Tower โ Houston, Texas
- Vermont Lung Center โ Colchester, Vermont
- American Family Childrens Hospital โ Madison, Wisconsin
- The Kids Research Institute Australia โ Nedlands,
- Women's and Children's Hospital โ North Adelaide,
- The Royal Children's Hospital โ Parkville,
- Queensland Children's Hospital โ South Brisbane,
- The Hospital for Sick Children โ Toronto,
- British Columbia Children's Hospital โ Vancouver,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis
- Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease โ Chapel Hill, North Carolina
- Hyperpolarized Imaging for New Treatments โ Cincinnati, Ohio
- Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI โ Cincinnati, Ohio
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older โ Nedlands,
- Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis โ Cincinnati, Ohio
Explore by condition: All Cystic Fibrosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.