A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

PHASE3CompletedINTERVENTIONAL
Enrollment

385

Participants

Timeline

Start Date

March 7, 2018

Primary Completion Date

February 5, 2019

Study Completion Date

February 5, 2019

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-659/TEZ/IVA

Participants received VX-659/TEZ/IVA orally once daily in the morning.

DRUG

IVA

Participants received IVA orally once daily in the evening.

DRUG

Placebo

Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.

Trial Locations (101)

10032

Columbia University Medical Center, New York

11040

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

12208

Albany Medical College, 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 University of Pittsburgh Medical Center, Pittsburgh

19017

Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center, Philadelphia

21287

The Johns Hopkins Hospital, Baltimore

27710

Duke University Medical Center, Durham

28277

Clinical Research of Charlotte, Charlotte

32806

Arnold Palmer Hospital, 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

37920

University of Tennessee Medical Center - Adult Cystic Fibrosis Clinic, Knoxville

Vanderbilt University Medical Center, Nashville

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

Kentucky Clinic, Lexington

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana Clinical Research Center, IU Health University Hospital, Indianapolis

48109

University of Michigan Health System, Ann Arbor

49503

Helen DeVos Children's Hospital CF Center, Grand Rapids

52242

The University of Iowa Hospitals and Clinics, Iowa City

55455

University of Minnesota, Minneapolis

57105

Sanford Research/ USD, Sioux Falls

60025

Cystic Fibrosis Center of Chicago, 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

Children's Mercy Hospital, Kansas City

73112

Respiratory Diseases of Children and Adolescents, Oklahoma City

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

80045

Children's Hospital Colorado, Aurora

80901

Rutgers-Robert Wood Johnson Medical School, New Brunswick

83712

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 & Allergy/Immunology Clinic, Spokane

06106

Hartford Health, Hartford

06511

Yale New Haven Medical Center, New Haven

02115

Boston Children's Hospital, Boston

01655

University of Massachusetts Memorial Medical Center, Worcester

03756

Dartmouth Hitchcock Medical Center, Lebanon, Lebanon

Unknown

The Alfred Hospital, Melbourne

Royal Adelaide Hospital, Adelaide

Prince Charles Hospital, Chermside

Royal Brisbane & Women's Hospital, Herston

Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital, Nedlands

John Hunter Hospital & Hunter Medical Research Institute, New Lambton Heights

Sydney Children's Hospital, Randwick, Randwick

Princess Margaret Hospital for Children, Subiaco

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

University Hospital Cologne, Cologne

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Clinic of J.W Goethe University, Frankfurt

Medizinische Hochschule Hannover, Hanover

Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder - und Jugendmedizin, Jena

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

Klinikum Innenstadt, University of Munich, München

Pneumologische Praxis Pasing, München

Beaumont Hospital, Dublin

Children's University Hospital Temple Street, Dublin

Cork University Hospital, Dublin

Our Lady's Children's Hospital, Dublin

St. Vincent's University Hospital, Dublin

National University of Ireland, Galway

University Hospital Limerick, 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

Instytut Matki i Dziecka, Warsaw

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

Coporacio Sanitaria Parc Tauli, Sabadell

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario y Politecnico La Fe, Valencia

Lindenhofspital - Quartier Bleu, Bern

Kinderspital Zuerich, Zurich

Universitaetsspital Zuerich, Zurich

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

Queen Elizabeth University Hospital, Glasgow

The Leeds Teaching Hospitals NHS Trust, 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

University Hospital Llandough, Penarth

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03447249 - A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Biotech Hunter | Biotech Hunter