At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 130 enrolled
Drug / intervention
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, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 130 participants across 55 sites in 11 countries.
Detailed Summary
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Ireland, Poland, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
First PostedMay 2018
Primary CompletionOct 2020
Study CompletionSep 2023
TodayJul 2026
First PostedMay 25, 2018
Enrollment StartApr 25, 2018
Primary CompletionOct 28, 2020
Study CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.1 years ago
Interventions
TEZ/IVAdrug
Fixed-dose combination tablet for oral administration.
IVAdrug
Tablet for oral administration.