At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 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, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
In Brief
A Phase 3 clinical trial evaluating LUM/IVA for Cystic Fibrosis. Completed, enrolled 52 participants across 23 sites in 2 countries.
Detailed Summary
This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartFeb 2020
Primary CompletionAug 2023
TodayJul 2026
First PostedJan 21, 2020
Enrollment StartFeb 24, 2020
Primary CompletionAug 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.4 years ago
Interventions
LUM/IVAdrug
LUM/IVA granules for oral administration