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A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Official title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
822
Start Date
2022-11-08
Completion Date
2026-10-30
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
VX-121/TEZ/D-IVA
Fixed-dose combination tablets for oral administration.
Locations (195)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Miller Children's Hospital / Long Beach Memorial
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente
Oakland, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco, Lung Transplant Program
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
University of Florida, Shands Hospital
Gainesville, Florida, United States
Joe DiMaggio Cystic Fibrosis & Pulmonary Center
Hollywood, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Central Florida Pulmonary Group,PA
Orlando, Florida, United States
Nemours Children's Specialty Care
Pensacola, Florida, United States
Johns Hopkins All Children's Hospital Outpatient Care Center
St. Petersburg, Florida, United States
The Emory Clinic at Chantilly
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Maine Medical Partners
Portland, Maine, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Spectrum Health Medical Group Adult Cystic Fibrosis Care Center
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Childrens Hospital University of Missouri Health Sciences Center
Columbia, Missouri, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital - St. Louis University
St Louis, Missouri, United States
Washington University School of Medicine / St. Louis Children's Hospital
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock
Manchester, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
Albany Medical College, Pulmonary and Critical Care Medicine
Albany, New York, United States
CF Therapeutics Development Center of Western New York
Buffalo, New York, United States
New York Medical College
Hawthorne, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Prisma Health Richland Campus
Columbia, South Carolina, United States
Sanford Children's Speciality Clinic
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Vanderbilt University Medical Center, Nephrology Clinical Trials Center
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Vermont Lung Center
Colchester, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, Australia
The Prince Charles Hospital
Chermside, Australia
Alfred Hospital
Melbourne, Australia
Institute for Respiratory Health
Nedlands, Australia
Telethon Kids Institute
Nedlands, Australia
The Royal Children's Hospital
Parkville, Australia
Mater Adult Hospital
South Brisbane, Australia
Queensland Children's Hospital
South Brisbane, Australia
Westmead Hospital
Westmead, Australia
University of Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde
Salzburg, Austria
Medizinische Universität Wien
Vienna, Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary, Canada
Stollery Children's Hospital
Edmonton, Canada
St. Joseph's Health Care London
London, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu
Montreal, Canada
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montreal, Canada
Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval
Québec, Canada
British Columbia Children's Hospital
Vancouver, Canada
St. Paul's Hospital
Vancouver, Canada
Klinika Detskych Infekcnich Nemoci
Brno, Czechia
Fakultni nemocnice v Motole
Prague, Czechia