Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
NCT ID: NCT05422222
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
210 participants
INTERVENTIONAL
2022-06-21
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: VX-121/TEZ/D-IVA
Participants will receive VX-121/TEZ/D-IVA in the morning.
VX-121/TEZ/D-IVA
Fixed-dose combination for oral administration.
Part B: VX-121/TEZ/D-IVA
Participants will receive VX-121/TEZ/D-IVA in the morning with the dose(s) to be based on the outcome of Part A.
VX-121/TEZ/D-IVA
Fixed-dose combination for oral administration.
Interventions
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VX-121/TEZ/D-IVA
Fixed-dose combination for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Year
11 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Cohen Children's Medical Center
Lake Success, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital - Wallace Tower
Houston, Texas, United States
Vermont Lung Center
Colchester, Vermont, United States
American Family Childrens Hospital
Madison, Wisconsin, United States
The Kids Research Institute Australia
Nedlands, , Australia
Women's and Children's Hospital
North Adelaide, , Australia
The Royal Children's Hospital
Parkville, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
The Hospital for Sick Children
Toronto, , Canada
British Columbia Children's Hospital
Vancouver, , Canada
CHU Lyon - Hopital Femme Mere-Enfant
Bron, , France
Hopital Necker, Enfants Malades
Paris, , France
Charité Universitätsmedizin BerlinX
Berlin, , Germany
Kinderklinik III, Abt. fur Pneumologie
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Erasmus Medical Center / Sophia Children's Hospital
Rotterdam, , Netherlands
Starship Children's Hospital
Grafton, , New Zealand
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Karolinska Universitetssjukhuset, Huddinge
Stockholm, , Sweden
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Kinderspital Zurich
Zurich, , Switzerland
Children and Young Adults Research Unit
Cardiff, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Central Contacts
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References
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Hoppe JE, Kasi AS, Pittman JE, Jensen R, Thia LP, Robinson P, Tirakitsoontorn P, Ramsey B, Mall MA, Taylor-Cousar JL, McKone EF, Tullis E, Salinas DB, Zhu J, Chen YC, Rodriguez-Romero V, Sosnay PR, Davies G; VX21-121-105 Study Group. Vanzacaftor-tezacaftor-deutivacaftor for children aged 6-11 years with cystic fibrosis (RIDGELINE Trial VX21-121-105): an analysis from a single-arm, phase 3 trial. Lancet Respir Med. 2025 Mar;13(3):244-255. doi: 10.1016/S2213-2600(24)00407-7. Epub 2025 Jan 2.
Other Identifiers
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2024-513754-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
VX21-121-105
Identifier Type: -
Identifier Source: org_study_id