A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

PHASE3CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

August 28, 2019

Primary Completion Date

June 12, 2020

Study Completion Date

June 12, 2020

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

FDC tablet for oral administration.

DRUG

IVA

Mono-tablet for oral administration.

DRUG

TEZ/IVA

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

Trial Locations (93)

10003

Mount Sinai Beth Israel, New York

10032

Columbia University Medical Center, New York

11040

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

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

27514

University of North Carolina Hospitals, Chapel Hill

32803

Central Florida Pulmonary Group, PA, Orlando

33136

University of Miami Miller School of Medicine, Miami

35233

University of Alabama at Birmingham, Birmingham

40536

University of Kentucky, Lexington

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

45220

UC Health Holmes, Cincinnati

46202

Indiana University, Indianapolis

52242

The University of Iowa Hospitals and Clinics, Iowa City

53792

University of Wisconsin Hospital and Clinics, Madison

55455

University of Minnesota, Minneapolis

63110

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

66160

University of Kansas Medical Center, Kansas City

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

The University of Texas Southwestern Medical Center, Dallas

77030

Texas Children's Hospital, Houston

78723

Dell Children's Medical Group, Austin

80206

National Jewish Health, Denver

84132

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

85724

Banner University of Arizona Medical Center, Tucson

90806

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

94143

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

94304

Stanford University, Palo Alto

95817

University of California Davis Medical Center, Sacramento

97239

Oregon Health & Science University, Portland

98195

University of Washington Medical Center, Seattle

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center, Boston

02115

Boston Children's Hospital, Boston

48109-5212

Michigan Medicine, Ann Arbor

03756

Dartmouth Hitchcock Medical Center, Lebanon

Unknown

The Prince Charles Hospital, Chermside

Alfred Hospital, Melbourne, VIC

Perth Children's Hospital, Nedlands

The Royal Children's Hospital, Parkville, VIC

Mater Adult Hospital, South Brisbane

Queensland Children's Hospital, South Brisbane

Westmead Hospital, Westmead

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Stollery Children's Hospital, Edmonton

McGill University Health Center, Québec

St. Michael's Hospital, Toronto

St. Paul's Hospital, Vancouver

Juliane Marie Center, Rigshospitalet, Copenhagen

Centre Hospitalier Lyon Sud, Benite Cedex

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

CHRU de Lille - Hopital Albert Calmette, Lille

CHU Marseille - Hopital Nord, Marseille

CHU de Montpellier - Hopital Arnaud de Villeneuve, Montpellier

Hopital Cochin, Paris

Hopital Necker, Enfants Malades, Paris

Hopital Pontchaillou CHU de Rennes, Rennes

Charite Paediatric Pulmonology Department, Berlin

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

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin, Giessen

Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie, Halle

Pneumologisches Studienzentrum Muenchen-West, München

University Hospital Wuerzburg, Würzburg

Cork University Hospital, Cork

Beaumont Hospital, Dublin

St. Vincent's University Hospital, Dublin

University Hospital Limerick (Adults), Limerick

Azienda Ospedaliero Universitaria Ospedale Riuniti, Ancona

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Malattie Apparato Respiratorio 2 - Fibrosi Cistica, Orbassano

Ospedale Pediatrico Bambino Gesu, Rome

Azienda Ospedaliera di Verona-Ospedale Civile Maggiore, Verona

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

UMC St. Radboud, Nijmegen

HagaZiekenhuis van den Haag, The Hague

Hospital Universitari Vall d´Hebron Servicio de Broncoscopia, Barcelona

Hospital Virgen de la Arrixaca, Murcia

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario y Politecnico La Fe, Valencia

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

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

Clinical Research Facility, Queen Elizabeth University 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

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT04058353 - A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Biotech Hunter | Biotech Hunter