At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
LUM/IVA +1 moredrug
Likely dose
LUM/IVA 400 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 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation
In Brief
A Phase 2 clinical trial evaluating LUM/IVA and Placebo for Cystic Fibrosis. Completed, enrolled 20 participants across 2 sites.
Detailed Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesNetherlands
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJan 2017
First PostedFeb 2017
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedFeb 23, 2017
Enrollment StartJan 31, 2017
Primary CompletionSep 6, 2017
Study CompletionOct 4, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.4 years ago
Interventions
LUM/IVAdrug
LUM 400 mg/IVA 250 mg every 12 hours (q12h)
Placebodrug
No Active Drug