A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

May 17, 2018

Primary Completion Date

December 21, 2018

Study Completion Date

December 21, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

TEZ/IVA

Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.

DRUG

IVA

Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.

DRUG

Placebo

Placebo matched to TEZ/IVA FDC

DRUG

Placebo

Placebo matched to IVA

Trial Locations (27)

Unknown

Hunter Medical Research Institute (HMRI), New Lambton Heights

Princess Margaret Hospital for Children, Perth

Lady Cilento Children's Hospital, South Brisbane

The Children's Hospital at Westmead, Westmead

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

University of Copenhagen Rigshospitalet, Copenhagen

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

Hôpital Necker - Enfants Malades, Paris

Universitaetsklinikum Koeln, Cologne

Universitaetsklinikum Essen, Essen

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen, Giessen

Medizinische Hochschule Hannover, Hanover

Universitaetsklinikum Heidelberg, Heidelberg

Universitaetsklinikum Jena, Jena

Universitaetsklinikum Tuebingen, Tübingen

Our Lady's Children's Hospital, Dublin

University Hospital Limerick, Limerick

Klinika Mukowiscydozy, Oddział Chorób Płuc SZP ZOZ, Dziekanów Leśny

Inselspital - Universitaetsspital Bern, Bern

Kinderspital Zuerich, Zurich

Royal Hospital for Sick Children, Edinburgh

Leeds General Infirmary, Leeds

Royal Brompton Hospital, London

Nottingham University Hospital City Campus, Nottingham

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03559062 - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis | Biotech Hunter | Biotech Hunter