Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Disease
Treatment
IVA
Placebo (matched to VX-121/TEZ/D-IVA)
VX-121/TEZ/D-IVA
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Heterozygous for F508del and a minimal function mutation (F/MF genotype)
Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted meanfor age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy;FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA
Exclusion
Key Exclusion Criteria:
History of solid organ or hematological transplantation
Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child PughScore 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
Lung infection with organisms associated with a more rapid decline in pulmonarystatus
Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Connect with a study center
Royal Prince Alfred Hospital
Camperdown,
AustraliaSite Not Available
The Prince Charles Hospital
Chermside,
AustraliaSite Not Available
Alfred Hospital
Melbourne, VIC,
AustraliaSite Not Available
Mater Adult Hospital
South Brisbane,
AustraliaSite Not Available
Queensland Children's Hospital
South Brisbane,
AustraliaSite Not Available
Westmead Hospital
Westmead,
AustraliaSite Not Available
Klinika Detskych Infekcnich Nemoci
Brno,
CzechiaSite Not Available
Fakultni nemocnice v Motole
Praha 5,
CzechiaSite Not Available
Charite Paediatric Pulmonology Department
Berlin,
GermanySite Not Available
St. Josef-Hospital
Bochum,
GermanySite Not Available
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
Erlangen,
GermanySite Not Available
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen,
GermanySite Not Available
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
Essen,
GermanySite Not Available
Johann Wolfgang Goethe University
Frankfurt,
GermanySite Not Available
Hannover Medical School
Hannover,
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover,
GermanySite Not Available
Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
Jena,
GermanySite Not Available
Johannes Gutenberg-Universitaet
Mainz,
GermanySite Not Available
Pneumologisches Studienzentrum Muenchen-West
Muenchen,
GermanySite Not Available
Klinikum Innenstadt, University of Munich
München,
GermanySite Not Available
Klinikum Westbrandenburg (CF)
Potsdam,
GermanySite Not Available
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)
Ulm,
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg,
GermanySite Not Available
National Koranyi Institute for TBC and Pulmonology
Budapest,
HungarySite Not Available
Pulmonology Institute Torokbalint
Torokbalint,
HungarySite Not Available
Cork University Hospital
Cork,
IrelandSite Not Available
Children's Health Ireland at Crumlin
Dublin,
IrelandSite Not Available
Children's Health Ireland at Tallaght
Dublin,
IrelandSite Not Available
Children's Health Ireland at Temple Street
Dublin,
IrelandSite Not Available
St. Vincent's University Hospital
Dublin,
IrelandSite Not Available
University Hospital Limerick (Adults)
Limerick,
IrelandSite Not Available
University Hospital Limerick (Pediatrics)
Limerick,
IrelandSite Not Available
Hadassah University Hospital Mount Scopus
Jerusalem,
IsraelSite Not Available
Schneider Children's Medical Center of Israel
Petach Tikvah,
IsraelSite Not Available
Sheba Medical Center - The Edmond and Lili Safra Children's Hospital
Tel HaShomer,
IsraelSite Not Available
Greenlane Clinical Centre
Auckland,
New ZealandSite Not Available
Starship Children's Hospital
Auckland,
New ZealandSite Not Available
Canterbury Respiratory Research Group
Christchurch Hospital,
New ZealandSite Not Available
Waikato Hospital
Hamilton,
New ZealandSite Not Available
Hospital de Santa Maria
Lisbon,
PortugalSite Not Available
CHP - Hospital de Santo Antonio
Porto,
PortugalSite Not Available
Hospital Sao Joao
Porto,
PortugalSite Not Available
Hospital Saint Joan de Deu
Barcelona,
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona,
SpainSite Not Available
Hospital Infantil Universitario Nino Jesus
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid,
SpainSite Not Available
Hospital Virgen de la Arrixaca
Murcia,
SpainSite Not Available
Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari
Sabadell,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Universitario y Politecnico La Fe
Valencia,
SpainSite Not Available
Sahlgrenska Universitetssjukhuset
Göteborg,
SwedenSite Not Available
Lund University Skanes Universitetssjukhus
Malmoe,
SwedenSite Not Available
Karolinska Universitetssjukhuset, Huddinge
Stockholm,
SwedenSite Not Available
Birmingham Heartlands Hospital
Birmingham,
United KingdomSite Not Available
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital
Bristol,
United KingdomSite Not Available
Royal Papworth Hospital NHS Foundation Trust
Cambridge,
United KingdomSite Not Available
Royal Hospital for Sick Children
Edinburgh,
United KingdomSite Not Available
Western General Hospital
Edinburgh,
United KingdomSite Not Available
Royal Devon and Exeter Hospital
Exeter,
United KingdomSite Not Available
Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow,
United KingdomSite Not Available
St. James University Hospital
Leeds,
United KingdomSite Not Available
Liverpool Heart and Chest Hospital
Liverpool,
United KingdomSite Not Available
King's College Hospital
London,
United KingdomSite Not Available
Royal Brompton Hospital
London,
United KingdomSite Not Available
St. Bartholomew's Hospital
London,
United KingdomSite Not Available
Wythenshawe Hospital
Manchester,
United KingdomSite Not Available
Clinical Research Facility
Newcastle Upon Tyne,
United KingdomSite Not Available
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
Penarth,
United KingdomSite Not Available
Southampton General Hospital
Southampton,
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Banner University of Arizona Medical Center
Tucson, Arizona 85724
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Miller Children's Hospital / Long Beach Memorial
Long Beach, California 90806
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Kaiser Permanente
Oakland, California 94611
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
University of California San Francisco, Lung Transplant Program
San Francisco, California 94143
United StatesSite Not Available
Children's Hospital of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
National Jewish Health
Denver, Colorado 80206
United StatesSite Not Available
University of Florida, Shands Hospital
Gainesville, Florida 32610
United StatesSite Not Available
Joe DiMaggio Cystic Fibrosis & Pulmonary Center
Hollywood, Florida 33021
United StatesSite Not Available
Central Florida Pulmonary Group, PA
Orlando, Florida 32803
United StatesSite Not Available
Nemours Children's Hospital
Orlando, Florida 32827
United StatesSite Not Available
Johns Hopkins All Children's Hospital Outpatient Care Center
Saint Petersburg, Florida 33701
United StatesSite Not Available
The Emory Clinic at Chantilly
Atlanta, Georgia 30324
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho 83702
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky 40202
United StatesSite Not Available
Tulane Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts 02114
United StatesSite Not Available
UMass Memorial Medical Center
Worcester, Massachusetts 01655
United StatesSite Not Available
Michigan Medicine
Ann Arbor, Michigan 48109-5212
United StatesSite Not Available
Helen DeVos Children's Hospital CF Center
Grand Rapids, Michigan 49503
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Childrens Hospital University of Missouri Health Sciences Center
Columbia, Missouri 65212
United StatesSite Not Available
The Children's Mercy Hospital
Kansas City, Missouri 64108
United StatesSite Not Available
Cardinal Glennon Children's Hospital - St. Louis University
Saint Louis, Missouri 63104
United StatesSite Not Available
Washington University School of Medicine / St. Louis Children's Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Billings Clinic
Billings, Montana 59101
United StatesSite Not Available
Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Dartmouth Hitchcock, Manchester
Manchester, New Hampshire 03104
United StatesSite Not Available
Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Albany Medical College
Albany, New York 12208
United StatesSite Not Available
CF Therapeutics Development Center of Western New York
Buffalo, New York 14203
United StatesSite Not Available
Northwell Health- Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
New York Medical College
Valhalla, New York 10595
United StatesSite Not Available
Atrium Health Levine Children's Hospital
Charlotte, North Carolina 28203
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104
United StatesSite Not Available
Cleveland Clinic CF
Cleveland, Ohio 44195
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Dayton Children's Hospital
Dayton, Ohio 45404
United StatesSite Not Available
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio 43606
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Sanford Children's Speciality Clinic
Sioux Falls, South Dakota 57105
United StatesSite Not Available
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesSite Not Available
Children's Foundation Research Center / Le Bonheur Children's Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Driscoll Children's Hospital
Corpus Christi, Texas 78411
United StatesSite Not Available
The University of Texas Southwestern Medical Center
Dallas, Texas 75390-8558
United StatesSite Not Available
Cook Children's Health Care System
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Utah - Primary Children's Medical Center
Salt Lake City, Utah 84132
United StatesSite Not Available
Vermont Lung Center
Colchester, Vermont 05446
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
Inova Fairfax
Falls Church, Virginia 22042
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United StatesSite Not Available
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