A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

January 9, 2023

Study Completion Date

January 9, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

Fixed-dose combination (FDC) tablet for oral administration.

DRUG

IVA

Tablet for oral administration.

Trial Locations (110)

10003

The Cystic Fibrosis Center, Mount Sinai Beth Israel, New York

10595

New York Medical College, Valhalla

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virginia Primary Care Center, Charlottesville

23298

Children's Hospital of Richmond at VCU, Children's Pavilion, Richmond

23507

Children's Hospital of the King's Daughters, Norfolk

26506

West Virginia University, Morgantown

27517

UNC Marsico Clinical Research Center, Chapel Hill

29425

Medical University of South Carolina, Charleston

30324

Children's Specialty Services at North Druid Hills, Atlanta

30912

Augusta University, Augusta

32207

Nemours Children's Specialty Care, Jacksonville

32610

University of Florida, Shands Hospital, Gainesville

32803

Central Florida Pulmonary Group, PA, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Joe DiMaggio Cystic Fibrosis & Pulmonary Center, Hollywood

33606

Tampa General Hospital Cardiac and Lung Transplant Clinic, Tampa

43205

Nationwide Children's Hospital, Columbus

43606

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

44106

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland

44308

Akron Children's Hospital, Akron

45220

UC Health Holmes, Cincinnati

45404

Dayton Children's Hospital, Dayton

48201

Harper University Hospital, Detroit

53226

CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital, Milwaukee

53792

University of Wisconsin Hospitals and Clinics, Madison

55404

Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota, Minneapolis

59101

Billings Clinic Hospital, Billings

60611

Ann & Robert Lurie Children's Hospital of Chicago, Chicago

Northwestern Memorial Hospital, Chicago

61637

Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center, Peoria

66160

The 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

75390

The University of Texas Southwestern Medical Center, Dallas

78723

Dell Children's Medical Center of Central Texas, Austin

80206

National Jewish Health, Denver

85724

Banner University of Arizona Medical Center, Tucson

87131

UNM Clinical and Translational Science Center, Albuquerque

90027

Children's Hospital Los Angeles, Los Angeles

90806

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

93636

Valley Children's Hospital, Madera

94143

UCSF Gateway Medical Center, San Francisco

94611

Kaiser Permanente, Oakland

95817

University of California Davis Medical Center, Sacramento

98195

University of Washington Medical Center, Seattle

04102

Maine Medical Partners, Portland

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center, Boston

07960

Morristown Medical Center, Morristown

05446

Vermont Lung Center, Colchester

Unknown

Women & Children's Hospital, North Adelaide

The Royal Children's Hospital, Parkville

Mater Misericordiae Ltd, South Brisbane

The Children's Hospital at Westmead, Westmead

Westmead Hospital, Westmead

University of Graz, Graz

Medizinische Universität Innsbruck, Innsbruck

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

Medizinische Universitat Wien, Vienna

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

UZ Antwerpen, Edegem

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

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

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

Centre Hospitalier De L'Universite Laval, Québec

The Hospital for Sick Children, Toronto

British Columbia's Children's Hospital, Vancouver

St. Paul's Hospital, Vancouver

Fakultni Nemocnice Brno, Brno

Fakultni nemocnice v Motole, Prague

Centre Hospitalier Lyon Sud, Benite Cedex

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

CHU Marseille - Hopital Nord, Marseille

CHU de Nice - Hopital Pasteur, Nice

Hopital Cochin, Paris

CHU de Rouen - Hopital Charles Nicolle, Rouen

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

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

Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin, Giessen

Hannover Medical School, Hanover

Johannes Gutenberg-Universitaet, Mainz

Dr. von Haunersches Kinderspital, München

Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin, Tübingen

University Hospital Wuerzburg, Würzburg

"General Hospital of Attika Sismanoglio(Adult CF center, NHS)", Marousi

Azienda Ospedaliero Universitaria Ospendali Riuniti, Ancona

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Florence

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

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

Azienda Ospedaliera di Verona-Ospedale Civile Maggiore, Verona

Academic Medical Center, Amsterdam

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

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

Karolinska Universitetssjukhuset, Huddinge, Stockholm

Belfast City Hospital, Belfast

Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital, Birmingham

Western General Hospital, Edinburgh

Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital, Exeter

Leeds General Infirmary, Leeds

King's College Hospital, London

Royal Manchester Children's Hospital, Manchester

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03525574 - A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | Biotech Hunter | Biotech Hunter