CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 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.

Search/NCT03150719
NCT03150719Phase 3Completed
CompareCT.gov

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted May 12, 2017·Updated Sep 12, 2019

In Brief

A Phase 3 clinical trial evaluating Tezacaftor/Ivacaftor, Ivacaftor, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 98 participants across 53 sites in 3 countries.

Detailed Summary

Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesFrance, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartMay 24, 2017
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 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.