At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
LUM/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 and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating LUM/IVA 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 evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if they meet the eligibility criteria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedJun 2016
Primary CompletionSep 2017
TodayJul 2026
First PostedJun 13, 2016
Enrollment StartMay 1, 2016
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.1 years ago
Interventions
LUM/IVAdrug