At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 71 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 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 71 participants across 21 sites in 5 countries.
Detailed Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Ireland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartOct 2018
Primary CompletionAug 2020
TodayJul 2026
First PostedOct 2, 2018
Enrollment StartOct 2, 2018
Primary CompletionAug 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed-dose combination tablet orally once daily in the morning.
IVAdrug
IVA tablet orally once daily in the evening.