At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 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 to Assess the Effect of Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 69 participants across 41 sites in 7 countries.
Detailed Summary
This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Czechia, France, Italy, Netherlands, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartJan 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedOct 22, 2020
Enrollment StartJan 15, 2021
Primary CompletionJul 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.7 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed dose combination (FDC) tablets for oral administration.
IVAdrug
Tablets for oral administration.