At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 82 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 Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age 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 82 participants across 19 sites in 4 countries.
Detailed Summary
This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartOct 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedJul 20, 2021
Enrollment StartOct 12, 2021
Primary CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.0 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed dose combination (FDC) tablet for oral administration.
IVAdrug
Tablet for oral administration.