Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
NCT ID: NCT05844449
Last Updated: 2025-12-17
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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ENROLLING_BY_INVITATION
PHASE3
174 participants
INTERVENTIONAL
2023-08-11
2029-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VNZ/TEZ/D-IVA
Part A: Participants (Cohort 1: 6 through 11 years of age (inclusive); Cohort 2: 2 through 5 years of age (inclusive) and Cohort 3: 1 to less than (\<) 2 years of age) will receive VNZ/TEZ/D-IVA once daily at doses determined based on their age and weight. The age range is based on date of informed consent in parent study.
Part B: Participants in Cohort 1 who meet the eligibility criteria will receive VNZ/TEZ/D-IVA for an additional 96 weeks.
VNZ/TEZ/D-IVA
Fixed-dose combination tablets or granules for oral administration.
Interventions
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VNZ/TEZ/D-IVA
Fixed-dose combination tablets or granules for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222)
Part B:
-Meets at least 1 of the following criteria:
* Completed study drug treatment in Part A
* Had study drug interruption(s) in Part A, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of Part A
Exclusion Criteria
* History of solid organ, hematological transplantation, or cancer
* History of drug intolerance in the parent study
1 Year
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 - 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 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
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 & 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
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
Countries
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Other Identifiers
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VX22-121-106
Identifier Type: -
Identifier Source: org_study_id
2022-503081-74-00
Identifier Type: OTHER
Identifier Source: secondary_id