A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

PHASE3CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

October 3, 2019

Primary Completion Date

July 24, 2020

Study Completion Date

July 24, 2020

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

FDC tablet for oral administration.

DRUG

TEZ/IVA

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

DRUG

IVA

Mono tablet for oral administration.

Trial Locations (35)

Unknown

The Prince Charles Hospital, Chermside

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

The Royal Children's Hospital, Parkville, VIC

Queensland Children's Hospital, South Brisbane

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

UZ Antwerpen, Edegem

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Charite Paediatric Pulmonology Department, Berlin

Universitaetsklinkum Koeln, CF-Studienzentrum, Cologne

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie, Essen

Johann Wolfgang Goethe University, Frankfurt

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

Klinikum Innenstadt, University of Munich, München

Pneumologisches Studienzentrum Muenchen-West, München

Belfast City Hospital, Belfast

University Hospitals Birmingham NHS Foundation Trust, Birmingham

University Hospitals Bristol NHS Foundation Trust, Bristol Royal Hospital, Bristol

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

Western General Hospital, Edinburgh

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

Leeds General Infirmary, Leeds, West Yorkshire

Alder Hey Children's Alder Hey Children's NHS Foundation Trust, Liverpool

Great Ormond Street Hospital for Sick Children, London

London and St Bartholomew's Hospital, London

The University Hospital of South Manchester, 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

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT04105972 - A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | Biotech Hunter | Biotech Hunter