At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 192 enrolled
Drug / intervention
Ivacaftordrug
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.
An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis
In Brief
A Phase 3 clinical trial evaluating Ivacaftor for Cystic Fibrosis. Completed, enrolled 192 participants across 58 sites in 8 countries.
Detailed Summary
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Czechia, France, Germany, Ireland, United Kingdom, United States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJul 2010
Primary CompletionMay 2014
TodayJul 2026
First PostedMay 5, 2010
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.2 years ago
Interventions
Ivacaftordrug