CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 458 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/NCT04043806
NCT04043806Phase 3Completed
CompareCT.gov

A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated·interventional·Posted Aug 2, 2019·Updated Jul 6, 2023

In Brief

A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 458 participants across 97 sites in 11 countries.

Detailed Summary

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 2, 2019
Enrollment StartAug 9, 2019
Primary CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.9 years ago

Interventions

ELX/TEZ/IVAdrug

Fixed-dose combination (FDC) tablet for oral administration.

IVAdrug

Tablet for oral administration.