At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 enrolled
Drug / intervention
TEZ +2 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 to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating TEZ, TEZ/IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 83 participants across 33 sites in 2 countries.
Detailed Summary
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedNov 2016
Primary CompletionSep 2018
TodayJul 2026
First PostedNov 2, 2016
Enrollment StartNov 1, 2016
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.7 years ago
Interventions
TEZdrug
TEZ/IVAdrug
IVAdrug