A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

May 4, 2020

Primary Completion Date

December 21, 2022

Study Completion Date

December 21, 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 (29)

Unknown

The Prince Charles Hospital, Chermside

Institute for Respiratory Health, Nedlands

Telethon Kids Institute, Perth Children's Hospital, Nedlands

The Royal Children's Hospital, Parkville, VIC

Queensland Children's Hospital, South Brisbane

Universitair Ziekenhuis Gent, Ghent

Universitair 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

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

Klinikum Innenstadt, University of Munich, München

Belfast City Hospital, Belfast

University Hospitals Birmingham NHS Foundation Trust, Birmingham

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

Royal Papworth Hospital NHS Foundation Trust, 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

Leeds General Infirmary, Leeds

St. James University Hospital, Leeds

Alder Hey Children's NHS Foundation Trust, Liverpool

Great Ormond Street Hospital for Sick Children, London

London and St Bartholomew's Hospital, London

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

NCT04362761 - A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy | Biotech Hunter | Biotech Hunter