At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 156 enrolled
Drug / intervention
Ivacaftor +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, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive
In Brief
A Phase 3 clinical trial evaluating Ivacaftor and Tezacaftor/Ivacaftor for Cystic Fibrosis. Completed, enrolled 156 participants across 68 sites in 10 countries.
Detailed Summary
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedApr 8, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.2 years ago
Interventions
Ivacaftordrug
Tezacaftor/Ivacaftordrug