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Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Official title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2023-08-11
Completion Date
2029-07-30
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
VNZ/TEZ/D-IVA
Fixed-dose combination tablets or granules for oral administration.
Locations (37)
Children's Hospital of Orange County
Orange, California, United States
Stanford University - Palo Alto - Pulmonology
Palo Alto, California, United States
Children's Hospital of Colorado - Pulmonology
Aurora, Colorado, United States
The Emory Clinic - Clifton Road - Pulmonology
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology
Chicago, Illinois, United States
JW Riley Hospital for Children - Pulmonology
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Health Care d/b/a Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
St. Louis Children's Hospital - Pulmonology
St Louis, Missouri, United States
Cohen Children's Medical Center - Lakeville Road
Lake Success, New York, United States
Cincinnati Children's Hospital Medical Center - Pulmonology
Cincinnati, Ohio, United States
UH Cleveland Medical Center - Pulmonology
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh - Pulmonology
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital - Wallace Tower - Pulmonology
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 & Children's Hospital
North Adelaide, Australia
The Royal Children's Hospital Melbourne
Parkville, Australia
Children's Health Queensland Hospital and Health Service
South Brisbane, Australia
Hospital for Sick Children - Pulmonology
Toronto, Canada
British Columbia Children's Hospital
Vancouver, Canada
Hopital Femme Mere-Enfant
Bron, France
Hopital Necker Enfants Malades - Pulmonology
Paris, France
Charite Paediatric Pulmonology Department
Berlin, Germany
Universitatsklinikum Essen
Essen, Germany
Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre
Hanover, Germany
Sophia Children's Hospital
Rotterdam, Netherlands
Starship Child Health
Grafton, New Zealand
Sahlgrenska Universitetssjukhuset - Göteborg CF-center
Gothenburg, Sweden
Karolinska University Hospital - Pulmonology
Stockholm, Sweden
Inselspital Bern
Bern, Switzerland
Kinderspital Zurich - Abteilung Pneumologie
Zurich, Switzerland
Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom