At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 507 enrolled
Drug / intervention
ELX/TEZ/IVA +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, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 507 participants across 110 sites in 13 countries.
Detailed Summary
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartOct 2018
Primary CompletionJan 2023
TodayJul 2026
First PostedMay 15, 2018
Enrollment StartOct 9, 2018
Primary CompletionJan 9, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.1 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed-dose combination (FDC) tablet for oral administration.
IVAdrug
Tablet for oral administration.