A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

PHASE3CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

June 19, 2020

Primary Completion Date

May 17, 2021

Study Completion Date

May 17, 2021

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

Fixed-dose combination tablet for oral administration qd in the morning.

DRUG

IVA

Tablet for oral administration qd in the evening.

OTHER

Placebo (matched to ELX/TEZ/IVA)

Placebo matched to ELX/TEZ/IVA for oral administration once daily (qd) in the morning.

OTHER

Placebo (matched to IVA)

Placebo matched to IVA for oral administration qd in the evening.

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

Universitätsklinikum Essen, 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, Petah Tikva

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

NCT04353817 - A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes | Biotech Hunter | Biotech Hunter