Science and Research

A Phase 3b, Randomized, Placebo-controlle Study Evaluating the Efficacy and Safety of Elexa-caftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Sub-jects 6 Through 11 Years of Age Who Are Hetero-zygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (VX19-445-116)

This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozy-gous for F508del and a minimal function (MF) mutation (F/MF
genotypes).

Study details
Study-ID: NCT04353817, 2019-003554-86
Study-ID: NCT04353817, 2019-003554-86
DZL Disease Area: CFBE
DZL Disease Area: CFBE
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL recruiting center
DZL Role: DZL recruiting center
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: BIH / Charité - Associated Partner, BREATH, TLRC, UGMLC
DZL Participating Sites: BIH / Charité - Associated Partner, BREATH, TLRC, UGMLC
Start Date: 01.06.2020
Completion Date: 20.07.2021
Status: Closed
Status: Closed
DZL recruiting center
Link to Study


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