At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 123 enrolled
Drug / intervention
VX-371 +4 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 2a, 2-part,Randomized, Double-blind, Placebo-controlled, Incomplete Block Crossover Study to Evaluate the Safety and Efficacy of VX-371 Solution for Inhalation With and Without Oral Ivacaftor in Subjects With Primary Ciliary Dyskinesia
In Brief
A Phase 2 clinical trial evaluating VX-371, Hypertonic Saline, and 3 other interventions for Primary Ciliary Dyskinesia. Completed, enrolled 123 participants across 34 sites in 8 countries.
Detailed Summary
To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Ciliary Dyskinesia
CountriesCanada, Denmark, Germany, Italy, Netherlands, Poland, United Kingdom, United States
CollaboratorsVertex Pharmaceuticals Incorporated
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedAug 2016
Primary CompletionNov 2018
TodayJul 2026
First PostedAug 18, 2016
Enrollment StartAug 1, 2016
Primary CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.9 years ago
Interventions
VX-371drug
Hypertonic Salinedrug
Placebo (0.17% saline)drug
VX-371 + HSdrug
Ivacaftordrug