Actively Recruiting
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-03-30
210
Participants Needed
38
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have stable cystic fibrosis.
- Must have at least one triple combination responsive mutation in the CFTR gene, including F508del.
- Age between 1 and 11 years old.
You will not qualify if you...
- History of solid organ, hematological transplantation, or cancer.
- Presence of hepatic cirrhosis with portal hypertension.
- Moderate hepatic impairment (Child Pugh Score 7 to 9).
- Severe hepatic impairment (Child Pugh Score 10 to 15).
- Current lung infection with organisms linked to rapid decline in lung function.
- Other protocol-defined exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Children's Hospital of Orange County
Orange, California, United States, 92868
Completed
2
Stanford University Clinical and Translational Research Unit
Palo Alto, California, United States, 94304
Completed
3
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
4
The Emory Clinic / Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Completed
5
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Completed
6
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
8
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Completed
9
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Completed
10
Washington University School of Medicine / St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Completed
11
Cohen Children's Medical Center
Lake Success, New York, United States, 11042
Completed
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Completed
13
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Completed
14
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Completed
15
Oregon Health & Science University
Portland, Oregon, United States, 97239
Completed
16
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Completed
17
Texas Children's Hospital - Wallace Tower
Houston, Texas, United States, 77030
Completed
18
Vermont Lung Center
Colchester, Vermont, United States, 05446
Completed
19
American Family Childrens Hospital
Madison, Wisconsin, United States, 53792
Completed
20
The Kids Research Institute Australia
Nedlands, Australia
Not Yet Recruiting
21
Women's and Children's Hospital
North Adelaide, Australia
Not Yet Recruiting
22
The Royal Children's Hospital
Parkville, Australia
Not Yet Recruiting
23
Queensland Children's Hospital
South Brisbane, Australia
Not Yet Recruiting
24
The Hospital for Sick Children
Toronto, Canada
Not Yet Recruiting
25
British Columbia Children's Hospital
Vancouver, Canada
Not Yet Recruiting
26
CHU Lyon - Hopital Femme Mere-Enfant
Bron, France
Not Yet Recruiting
27
Hopital Necker, Enfants Malades
Paris, France
Not Yet Recruiting
28
Charité - Paediatric Pulmonology Department
Berlin, Germany
Not Yet Recruiting
29
Universitatsklinikum Essen
Essen, Germany
Not Yet Recruiting
30
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
31
Erasmus Medical Center / Sophia Children's Hospital
Rotterdam, Netherlands
Not Yet Recruiting
32
Starship Children's Hospital
Grafton, New Zealand
Completed
33
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Completed
34
Karolinska University Hospital - Pulmonology
Stockholm, Sweden
Not Yet Recruiting
35
Inselspital - Universitaetsspital Bern
Bern, Switzerland
Actively Recruiting
36
Kinderspital Zurich
Zurich, Switzerland
Not Yet Recruiting
37
Children and Young Adults Research Unit
Cardiff, United Kingdom
Not Yet Recruiting
38
Great Ormond Street Hospital for Children
London, United Kingdom
Not Yet Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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