At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 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 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating IVA for Cystic Fibrosis. Completed, enrolled 57 participants across 23 sites in 5 countries.
Detailed Summary
The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Ireland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionJun 2022
TodayJul 2026
First PostedApr 1, 2016
Enrollment StartJun 2, 2016
Primary CompletionJun 28, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 10.3 years ago
Interventions
IVAdrug
Granules in sachet for oral administration.