At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 33 enrolled
Drug / intervention
Ivacaftordrug
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, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation
In Brief
A Phase 3 clinical trial evaluating Ivacaftor for Cystic Fibrosis. Completed, enrolled 33 participants across 16 sites in 3 countries.
Detailed Summary
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United Kingdom, United States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartDec 2013
Primary CompletionDec 2015
TodayJul 2026
First PostedSep 19, 2013
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.8 years ago
Interventions
Ivacaftordrug