At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
Lumacaftor +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, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating Lumacaftor and Ivacaftor for Cystic Fibrosis. Completed, enrolled 62 participants across 20 sites in 2 countries.
Detailed Summary
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionOct 2015
TodayJul 2026
First PostedJul 11, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.0 years ago
Interventions
Lumacaftordrug
Ivacaftordrug