CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Tezacaftor/Ivacaftor +3 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.

Search/NCT02508207
NCT02508207Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Jul 24, 2015·Updated Jul 19, 2021

In Brief

A Phase 2 clinical trial evaluating Tezacaftor/Ivacaftor, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 34 participants across 7 sites.

Detailed Summary

To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 24, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Tezacaftor/Ivacaftordrug

Tezacaftor/Ivacaftor FDC

Ivacaftordrug

Tezacaftor/Ivacaftor matching placebodrug

Ivacaftor matching placebodrug