A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

PHASE3CompletedINTERVENTIONAL
Enrollment

405

Participants

Timeline

Start Date

June 15, 2018

Primary Completion Date

April 24, 2019

Study Completion Date

April 24, 2019

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-445/TEZ/IVA

Participants received VX-445/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-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.

Trial Locations (115)

10003

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 Speciality 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, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital, 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

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

60611

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

Northwestern Memorial Hospital, Chicago

61637

Saint Francis Medical Center/ Children's Hospital of Illinois/OSF, Peoria

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

75390

The University of Texas Southwestern Medical Center, Dallas

75708

The University of Texas Health Science Center at Tyler, Tyler

78723

Austin Children's Chest Associates, Austin

80206

National Jewish Health, Denver

85724

Banner University of Arizona Medical Center, Tucson

87131

University of New Mexico Clinical & 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/ Children's Hospital of Central California, 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, 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 Adult Hospital, South Brisbane

The Children's Hospital at Westmead, Westmead

Westmead Hospital, Westmead

University of Graz, Graz

Medizinische Universitat 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 Gathuisberg, Leuven

British Columbia's Children's Hospital, Vancouver

St. Paul's Hospital, Vancouver

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

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

Centre Hospitalier De L'Universite Laval, Qubec

Saint John Regional Hospital, Saint John

The Hospital for Sick Children, Toronto

Vancouver Island Health Authority, Victoria

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 Cedex, Seine Maritime

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

Heidelberg Cystic Fibrosis Center, Heidelberg

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 Ospedale 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 Univeritetssjukhuset, Huddinge, Stockholm

The Royal Belfast Hospital for Sick Children, Belfast

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

Royal Hospital for Sick Children, Edinburgh

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

NCT03525444 - A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Biotech Hunter | Biotech Hunter