At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
IVAdrug
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, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation
In Brief
A Phase 3 clinical trial evaluating IVA for Cystic Fibrosis. Completed, enrolled 86 participants across 29 sites in 6 countries.
Detailed Summary
This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an approved Ivacaftor-Responsive mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Germany, Ireland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedSep 2017
Primary CompletionOct 2023
TodayJul 2026
First PostedSep 8, 2017
Enrollment StartAug 16, 2017
Primary CompletionOct 2, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 8.8 years ago
Interventions
IVAdrug
Granules for oral administration.