๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-27

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Vertex Pharmaceuticals Incorporated

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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,

๐Ÿ’ฐ 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.

Explore by condition: All Cystic Fibrosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—