At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,164 enrolled
Drug / intervention
Lumacaftor Plus Ivacaftor Combination +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 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating Lumacaftor Plus Ivacaftor Combination and Ivacaftor for Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation. Completed, enrolled 1,164 participants across 166 sites in 15 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartOct 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedAug 29, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.8 years ago
Interventions
Lumacaftor Plus Ivacaftor Combinationdrug
Fixed dose combination tablet, oral use
Ivacaftordrug
Film-coated tablet, oral use