Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
Official Title
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
Quick Facts
Study Start:2022-06-21
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Children's Hospital of Orange County
Orange, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
The Emory Clinic / Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Washington University School of Medicine / St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Cohen Children's Medical Center
New York, New York, 11042
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030
United States
Vermont Lung Center
Colchester, Vermont, 05446
United States
American Family Childrens Hospital
Madison, Wisconsin, 53792
United States
Collaborators and Investigators
Sponsor: Vertex Pharmaceuticals Incorporated
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2022-06-21
Study Completion Date2030-06
Study Record Updates
Study Start Date2022-06-21
Study Completion Date2030-06
Terms related to this study
Additional Relevant MeSH Terms