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

PHASE3CompletedINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

August 9, 2019

Primary Completion Date

December 14, 2022

Study Completion Date

December 14, 2022

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

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

DRUG

IVA

Tablet for oral administration.

Trial Locations (97)

10032

Columbia University Medical Center, New York

11040

Northwell Health- Long Island Jewish Medical Center, New Hyde Park

12208

Albany Medical College, Pulmonary and Critical Care Medicine, Albany

13210

SUNY Upstate Medical University, Syracuse

14222

Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

21287

Johns Hopkins Hospital, Baltimore

27710

Duke University Medical Center, Durham

28277

Clinical Research of Charlotte, Charlotte

32806

Arnold Palmer Hospital Pulmonary and Sleep Medicine, Orlando

33136

University of Miami Miller School of Medicine, Miami

33155

Nicklaus Children's Hospital, 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, Nashville

37920

University of Tennessee Medical Center, Knoxville

38103

Children's Foundation Research Center / Le Bonheur Children's Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Kosair Charities Pediatric Clinical Research Unit, Louisville

40536

University of Kentucky, Lexington

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana University, Indianapolis

52242

The University of Iowa Hospitals and Clinics, Iowa City

55455

University of Minnesota, Minneapolis

57105

Sanford Children's Speciality Clinic, Sioux Falls

60025

Cystic Fibrosis Institute, Glenview

60714

Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants, Niles

63110

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

64108

The Children's Mercy Hospital, Kansas City

73112

Santiago Reyes, M.D., Oklahoma City

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

83702

St. Luke's CF Center of Idaho, Boise

84132

University of Utah / Primary Children's Medical Center, Salt Lake City

94304

Stanford University, Palo Alto

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

99204

Providence Pediatric Pulmonary & Cystic Fibrosis Clinic, Spokane

06102

Hartford Hospital, Hartford

06510

Yale New Haven Hospital, New Haven

02115

Boston Children's Hospital, Boston

01655

UMass Memorial Medical Center, Worcester

48109-5212

Michigan Medicine, Ann Arbor

03756

Dartmouth Hitchcock Medical Center, Lebanon

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

Unknown

Royal Adelaide Hospital, Adelaide

The Prince Charles Hospital, Chermside

Alfred Hospital, Melbourne, VIC

Institute for Respiratory Health, Nedlands

Perth Children's Hospital, Nedlands

John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital, New Lambton

Queensland Children's Hospital, South Brisbane

Stollery Children's Hospital, Edmonton

Queen Elizabeth II Health Sciences Center, Halifax

St. Michael's Hospital, Toronto

Juliane Marie Center, Rigshospitalet, Copenhagen

Charite Paediatric Pulmonology Department, Berlin

Universitaetsklinkum Koeln, CF-Studienzentrum, Cologne

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Johann Wolfgang Goethe University, Frankfurt

Hannover Medical School, Hanover

Universitaetsklinikum Jena, Mukoviszidose-Zentrum, Jena

Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Lübeck

Klinikum Innenstadt, University of Munich, München

Pneumologisches Studienzentrum Muenchen-West, München

Cork University Hospital, Cork

Beaumont Hospital, Dublin

Children's Health Ireland at Crumlin, Dublin

Children's Health Ireland at Temple Street, Dublin

St. Vincent's University Hospital, Dublin

University Hospital Galway, Galway

University Hospital Limerick (Adults), Limerick

Lady Davis Carmel Medical Center, Haifa

Pediatric Pulmonary Unit Rambam Medical Center, Haifa

Hadassah Medical Organization, Jerusalem

Schneider Children's Medical Center, Petah Tikva

Sheba Medical Center, Tel Litwinsky

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

Hospital Universitari Vall d Hebron, Barcelona

Hospital Universitari Vall d´Hebron Servicio de Broncoscopia, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Infantil La Paz, Madrid

Parc Tauli Sabadell Hospital Universitari, Sabadell

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario y Politecnico La Fe, Valencia

Lindenhofspital - Quartier Bleu, Bern

Kinderspital Zuerich, Zurich

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

NHS Greater Glasgow and Clyde, Gartnavel General Hospital, Glasgow

St. James University Hospital, Leeds

Liverpool Heart and Chest Hospital, Liverpool

Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital, London

Wythenshawe Hospital, Manchester

The Newcastle upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary, Newcastle upon Tyne

Nottingham University Hospitals NHS Trust, Queens Medical Center, Nottingham

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

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT04043806 - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Biotech Hunter | Biotech Hunter