At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
LUM/IVA +2 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.
An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
In Brief
A Phase 2 clinical trial evaluating LUM/IVA and Placebo for Cystic Fibrosis. Completed, enrolled 51 participants across 5 sites.
Detailed Summary
This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartAug 2018
Primary CompletionOct 2020
Study CompletionOct 2021
TodayJul 2026
First PostedAug 10, 2018
Enrollment StartAug 10, 2018
Primary CompletionOct 9, 2020
Study CompletionOct 7, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago
Interventions
LUM/IVAdrug
FDC tablets or granules for oral administration.
LUM/IVAdrug
FDC granules for oral administration.
Placebodrug
Placebo matched to LUM/IVA for oral administration.