CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 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/NCT04183790
NCT04183790Phase 3Completed
CompareCT.gov

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of ELX/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Vertex Pharmaceuticals Incorporated·interventional·Posted Dec 3, 2019·Updated May 18, 2025

In Brief

A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 64 participants across 21 sites in 5 countries.

Detailed Summary

The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Ireland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 3, 2019
Enrollment StartFeb 17, 2020
Primary CompletionFeb 24, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.6 years ago

Interventions

ELX/TEZ/IVAdrug

Fixed-dose combination (FDC) tablet for oral administration

IVAdrug

Mono tablet for oral administration.