At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 172 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.
A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 172 participants across 29 sites in 4 countries.
Detailed Summary
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Germany, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartMay 2020
Primary CompletionDec 2022
TodayJul 2026
First PostedApr 27, 2020
Enrollment StartMay 4, 2020
Primary CompletionDec 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.2 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed-dose combination (FDC) tablet for oral administration.
IVAdrug
Tablet for oral administration.