CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 enrolled
Drug / intervention
ELX/TEZ/IVA +1 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/NCT05111145
NCT05111145Phase 3Completed
CompareCT.gov

A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated·interventional·Posted Nov 8, 2021·Updated Jul 11, 2023

In Brief

A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 86 participants across 24 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, Czechia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 8, 2021
Enrollment StartJan 14, 2022
Primary CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.6 years ago

Interventions

ELX/TEZ/IVAdrug

Fixed-dose combination tablets for oral administration.

IVAdrug

Tablets for oral administration.