At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 248 enrolled
Drug / intervention
VX-661/Ivacaftor +3 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, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and 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 Allele With a CFTR Mutation Predicted to Have Residual Function
In Brief
A Phase 3 clinical trial evaluating VX-661/Ivacaftor, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 248 participants across 93 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionFeb 2017
TodayJul 2026
First PostedMar 18, 2015
Enrollment StartMar 1, 2015
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.3 years ago
Interventions
VX-661/Ivacaftordrug
Fixed dose combination tablet, oral use
Ivacaftordrug
Tablet, oral use
Placebo matched to VX-661/ ivacaftordrug
Fixed dose combination tablet, oral use
Placebo matched to Ivacaftordrug
Tablet, oral use