NCT03625466View on ClinicalTrials.gov

A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 10, 2018

Primary Completion Date

October 9, 2020

Study Completion Date

October 7, 2021

Conditions
Cystic Fibrosis
Interventions
DRUG

LUM/IVA

FDC tablets or granules for oral administration.

DRUG

LUM/IVA

FDC granules for oral administration.

DRUG

Placebo

Placebo matched to LUM/IVA for oral administration.

Trial Locations (5)

Unknown

Charite Paediatric Pulmonology Department, Berlin

Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin, Giessen

Hannover Medical School, Hanover

Heidelberg Cystic Fibrosis Center, Heidelberg

Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Lübeck

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03625466 - A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Biotech Hunter | Biotech Hunter