At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 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 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 83 participants across 22 sites in 5 countries.
Detailed Summary
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Germany, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionJun 2022
TodayJul 2026
First PostedSep 3, 2020
Enrollment StartNov 19, 2020
Primary CompletionJun 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.8 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed dose combination granules for oral administration.
IVAdrug
Granules for oral administration.