At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
LUM/IVA +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 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
In Brief
A Phase 4 clinical trial evaluating LUM/IVA and Placebo for Cystic Fibrosis. Completed, enrolled 70 participants across 12 sites in 2 countries.
Detailed Summary
This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedAug 23, 2016
Enrollment StartSep 1, 2016
Primary CompletionSep 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.9 years ago
Interventions
LUM/IVAdrug
Placebodrug