At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 39 enrolled
Drug / intervention
Ivacaftor +1 moredrug
Likely dose
Ivacaftor 150 mgfrom 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, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation
In Brief
A Phase 3 clinical trial evaluating Ivacaftor and Placebo for Cystic Fibrosis. Completed, enrolled 39 participants across 12 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBelgium, France, United States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedJun 8, 2012
Enrollment StartJul 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.1 years ago
Interventions
Ivacaftordrug
150 mg tablet, oral use, administered twice a day (q12h)
Placebodrug
oral use, administered twice a day (q12h)