At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 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, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating LUM/IVA for Cystic Fibrosis. Completed, enrolled 57 participants across 20 sites in 2 countries.
Detailed Summary
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionJul 2019
TodayJul 2026
First PostedApr 24, 2017
Enrollment StartMay 12, 2017
Primary CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.2 years ago
Interventions
LUM/IVAdrug
Participants received LUM/IVA every q12h.