At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 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 Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 120 participants across 34 sites in 10 countries.
Detailed Summary
The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with 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 PostedSep 2020
Enrollment StartJan 2021
Primary CompletionMar 2023
TodayJul 2026
First PostedSep 11, 2020
Enrollment StartJan 11, 2021
Primary CompletionMar 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed dose combination (FDC) tablets for oral administration.
IVAdrug
Tablet for oral administration.