A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

822

Participants

Timeline

Start Date

November 8, 2022

Primary Completion Date

October 30, 2026

Study Completion Date

October 30, 2026

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-121/TEZ/D-IVA

Fixed-dose combination tablets for oral administration.

Trial Locations (195)

10032

Columbia University Medical Center, New York

10595

New York Medical College, Valhalla

11040

Long Island Jewish Medical Center, New Hyde Park

12208

Albany Medical College, Pulmonary and Critical Care Medicine, Albany

13210

SUNY Upstate Medical University, Syracuse

14203

CF Therapeutics Development Center of Western New York, Buffalo

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virginia Health System, Charlottesville

26506

West Virginia University, Morgantown

27104

Wake Forest Baptist Health, Winston-Salem

28207

Atrium Health Levine Children's Hospital, Charlotte

29203

Prisma Health Richland Campus, Columbia

30324

The Emory Clinic at Chantilly, Atlanta

30912

Augusta University, Augusta

32514

Nemours Children's Specialty Care, Pensacola

32610

University of Florida, Shands Hospital, Gainesville

32803

Central Florida Pulmonary Group,PA, Orlando

33021

Joe DiMaggio Cystic Fibrosis & Pulmonary Center, Hollywood

33136

University of Miami Miller School of Medicine, Miami

33701

Johns Hopkins All Children's Hospital Outpatient Care Center, St. Petersburg

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nephrology Clinical Trials Center, Nashville

37920

University of Tennessee Medical Center, Knoxville

40508

University of Kentucky, Lexington

43205

Nationwide Children's Hospital, Columbus

43606

ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center, Toledo

44308

Akron Children's Hospital, Akron

45404

Dayton Children's Hospital, Dayton

46202

Indiana University, Indianapolis

Riley Hospital for Children at Indiana University Health, Indianapolis

48109

Michigan Medicine, Ann Arbor

48201

Harper University Hospital, Detroit

49546

Spectrum Health Medical Group Adult Cystic Fibrosis Care Center, Grand Rapids

53792

University Hospital and UW Health Clinics, Madison

55455

University of Minnesota, Minneapolis

57105

Sanford Children's Speciality Clinic, Sioux Falls

59101

Billings Clinic, Billings

60611

Northwestern Memorial Hospital, Chicago

63104

Cardinal Glennon Children's Hospital - St. Louis University, St Louis

63110

Washington University School of Medicine / St. Louis Children's Hospital, St Louis

64108

The Children's Mercy Hospital, Kansas City

65212

Childrens Hospital University of Missouri Health Sciences Center, Columbia

66160

University of Kansas Medical Center, Kansas City

68198

Nebraska Medical Center, Omaha

70112

Tulane Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73112

Santiago Reyes, M.D., Oklahoma City

75390

The University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Health Care System, Fort Worth

77030

Texas Children's Hospital - Baylor College of Medicine, Houston

80045

Children's Hospital of Colorado, Aurora

80206

National Jewish Health, Denver

83702

St. Luke's Cystic Fibrosis Center of Idaho, Boise

84132

University of Utah, Salt Lake City

85724

Banner University of Arizona Medical Center, Tucson

90027

Children's Hospital Los Angeles, Los Angeles

90806

Miller Children's Hospital / Long Beach Memorial, Long Beach

94143

University of California San Francisco, Lung Transplant Program, San Francisco

94611

Kaiser Permanente, Oakland

95817

University of California Davis Medical Center, Sacramento

97239

Oregon Health & Science University, Portland

98195

University of Washington Medical Center, Seattle

99204

Providence Pediatric Pulmonary & Cystic Fibrosis Clinic, Spokane

04102

Maine Medical Partners, Portland

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center, Boston

02115

Boston Children's Hospital, Boston

01655

UMass Memorial Medical Center, Worcester

03104

Dartmouth Hitchcock, Manchester

07960

Morristown Medical Center, Morristown

05446

Vermont Lung Center, Colchester

Unknown

Royal Prince Alfred Hospital, Camperdown

The Prince Charles Hospital, Chermside

Alfred Hospital, Melbourne

Institute for Respiratory Health, Nedlands

Telethon Kids Institute, Nedlands

The Royal Children's Hospital, Parkville

Mater Adult Hospital, South Brisbane

Queensland Children's Hospital, South Brisbane

Westmead Hospital, Westmead

University of Graz, Graz

Medizinische Universität Innsbruck, Innsbruck

Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde, Salzburg

Medizinische Universität Wien, Vienna

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

University of Calgary Medical Clinic of the Foothills Medical Centre, Calgary

Stollery Children's Hospital, Edmonton

St. Joseph's Health Care London, London

Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu, Montreal

McGill University Health Centre, Glen Site, Montreal Children's Hospital, Montreal

Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval, Québec

British Columbia Children's Hospital, Vancouver

St. Paul's Hospital, Vancouver

Klinika Detskych Infekcnich Nemoci, Brno

Fakultni nemocnice v Motole, Prague

Aarhus University Hospital, Aarhus

Juliane Marie Center, Rigshospitalet, Copenhagen

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

CHU Lyon - Hopital Femme Mere-Enfant, Bron

Centre Hospitalier Intercommunal Creteil, Créteil

Institut Cœur Poumon, CHU de Lille, Lille

Hopital Arnaud de Villeneuve, Montpellier

Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur, Nice

Hopital Cochin, Paris

Hopital Robert Debre, Paris

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre de Perharidy, Roscoff

CHU de Rouen - Hopital Charles Nicolle, Rouen

Hôpital de Hautepierre, AX5, Strasbourg

Hopital Foch (Suresnes), Hopital Foch, Adultes, Suresnes

Hopital Bretonneau, Tours

Charite Paediatric Pulmonology Department, Berlin

Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital, Erlangen

Kinderklinik III, Abt. fur Pneumologie, Essen

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Johann Wolfgang Goethe University, Frankfurt

Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin, Giessen

Hannover Medical School, Hanover

Medizinische Hochschule Hannover, Hanover

Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Jena

Johannes Gutenberg-Universitaet, Mainz

Pneumologisches Studienzentrum Muenchen-West, München

Klinikum Westbrandenburg (CF), Potsdam

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF), Ulm

Universitätsklinikum Würzburg, Würzburg

"General Hospital of Thessaloniki Papanikolaou", Thessaloniki

General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki, Thessaloniki

National Koranyi Institute for TBC and Pulmonology, Budapest

Pulmonology Institute Torokbalint, Törökbálint

Cork University Hospital, Cork

Children's Health Ireland at Crumlin, Dublin

Children's Health Ireland at Temple Street, Dublin

St. Vincent's University Hospital, Dublin

University Hospital Limerick (Pediatrics), Limerick

Hadassah Medical Organization, Jerusalem

Schneider Children's Medical Center of Israel, Petach Tikvah

Sheba Medical Center - The Edmond and Lili Safra Children's Hospital, Tel Litwinsky

Azienda Ospedaliero Universitaria Ospedale Riuniti, Ancona

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Florence

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica, Orbassano

Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo, Potenza

Azienda Ospedaliera di Verona - Ospedale Civile Maggiore, Verona

Academisch Medisch Centrum (Academic Medical Centre), Amsterdam

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis, Utrecht

Canterbury District Health Board, Christchurch

Starship Children's Hospital, Grafton

Waikato Hospital, Hamilton

Greenlane Clinical Centre, One Tree Hill

Haukeland Universitetssjukehus (CF), Bergen

Oslo University Hospital, Department of Paediatric Medicine, Oslo

Pediatric Hospital Polanki named of Maciej Płażyński, Gdansk

Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY, Łomianki

Hospital de Santa Maria, Lisbon

CHP - Hospital de Santo Antonio, Porto

Hospital Sao Joao, Porto

Hospital Saint Joan de Deu, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Ramon y Cajal, Madrid

Hospital Virgen de la Arrixaca, Murcia

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari, Sabadell

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario y Politecnico La Fe, Valencia

Sahlgrenska Universitetssjukhuset, Gothenburg

Lund University Skanes Universitetssjukhus, Lund

Karolinska Universitetssjukhuset, Huddinge, Stockholm

Kinderspital Zuerich, Zurich

Birmingham Heartlands Hospital, Birmingham

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital, Bristol

Royal Papworth Hospital NHS Foundation Trust, Cambridge

Western General Hospital, Edinburgh

Royal Devon University Healthcare NHS Foundation Trust, Exeter

Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow

Leeds General Infirmary, Leeds

St. James University Hospital, Leeds

Liverpool Heart and Chest Hospital, Liverpool

King's College Hospital, London

Royal Brompton Hospital, London

St. Bartholomew's Hospital, London

Royal Manchester Children's Hospital, Manchester

Wythenshawe Hospital, Manchester

Clinical Research Facility, Newcastle upon Tyne

All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough, Penarth

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY