At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Tezacaftor/Ivacaftor +3 moredrug
Likely dose
Tezacaftor/Ivacaftor 100 mgfrom 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 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
In Brief
A Phase 2 clinical trial evaluating Tezacaftor/Ivacaftor, Ivacaftor, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 41 participants across 9 sites.
Detailed Summary
The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartSep 2016
Primary CompletionJul 2018
TodayJul 2026
First PostedApr 6, 2016
Enrollment StartSep 1, 2016
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago
Interventions
Tezacaftor/Ivacaftordrug
TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.
Ivacaftordrug
IVA 150 mg tablet.
Placebodrug
Placebo matched to TEZ/IVA fixed-dose combination tablet.
Placebodrug
Placebo matched to IVA tablet.