NCT05422222Active, not recruitingPhase 3
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 13 Jun 2022
- Start date
- Jun 2022
- Primary completion date
- Jun 2030
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT05422222
- EU CT number
- 2024-513754-29-00
- EudraCT number
- 2021-005930-40
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 210
- From Jun 2022 to the primary completion date, Jun 2030
- 41 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of solid organ, hematological transplantation, or cancer
- Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene
Age in the registry: 1 year to 11 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Kids Research Institute Australia Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Women's and Children's Hospital Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| The Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Inselspital - Universitaetsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
| Hospital Femme Mere Enfant Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Children and Young Adults Research Unit Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Children's Health Ireland Coordinator of this site? Confirm its status | Dublin 12 | Ireland | Not yet recruiting |
| University Hospital Limerick Coordinator of this site? Confirm its status | Limerick | Ireland | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Starship Children's Hospital Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Recruiting |
| The Emory Clinic / Children's Healthcare of Atlanta at Egleston Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Vermont Lung Center Coordinator of this site? Confirm its status | Colchester | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Children's Hospital - Wallace Tower Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| The Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cohen Children's Medical Center Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| American Family Childrens Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Stanford University Clinical and Translational Research Unit Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Washington University School of Medicine/St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.