CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
ELX/TEZ/IVA +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04353817
NCT04353817Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Vertex Pharmaceuticals Incorporated·interventional·Posted Apr 20, 2020·Updated Jul 26, 2022

In Brief

A Phase 3 clinical trial evaluating ELX/TEZ/IVA, IVA, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 121 participants across 34 sites in 10 countries.

Detailed Summary

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 heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 20, 2020
Enrollment StartJun 19, 2020
Primary CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.2 years ago

Interventions

ELX/TEZ/IVAdrug

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

IVAdrug

Tablet for oral administration qd in the evening.

Placebo (matched to ELX/TEZ/IVA)other

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

Placebo (matched to IVA)other

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