A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

March 24, 2023

Study Completion Date

March 24, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

Fixed dose combination (FDC) tablets for oral administration.

DRUG

IVA

Tablet for oral administration.

Trial Locations (34)

Unknown

Telethon Kids Institute, Nedlands

Queensland Children's Hospital, South Brisbane

The Children's Hospital at Westmead, Westmead

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

The Hospital for Sick Children, Toronto

British Columbia Children's Hospital, Vancouver

Juliane Marie Center, Rigshospitalet, Copenhagen

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

CHU Lyon - Hopital Femme Mere-Enfant, Bron

Hopital Necker, Enfants Malades, Paris

Hopital Robert Debre, Paris

Centre de Perharidy, Roscoff

Charite Paediatric Pulmonology Department, Berlin

Universitaetsklinkum Koeln, CF-Studienzentrum, Cologne

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

Johann Wolfgang Goethe University, Frankfurt

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

Medizinische Hochschule Hannover, Hanover

Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin, Heidelberg

Hadassah University Hospital Mount Scopus, Jerusalem

Schneider Children's Medical Center of Israel, Petach Tikvah

Universitair Medisch Centrum Groningen, Groningen

Erasmus Medical Center / Sophia Children's Hospital, Rotterdam

Hospital Universitari Vall d Hebron, Barcelona

Hospital Virgen de la Arrixaca, Murcia

Inselspital - Universitaetsspital Bern, Bern

Kinderspital Zuerich, Zurich

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

Children's Hospital of Wales, Cardiff

Royal Hospital for Sick Children, Edinburgh

Alder Hey Children's NHS Foundation Trust, Liverpool

Great Ormond Street Hospital for Sick Children, London

Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital, London

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT04545515 - A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes | Biotech Hunter | Biotech Hunter