CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 46 enrolled
Drug / intervention
Lumacaftor +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.

Search/NCT02390219
NCT02390219Phase 3Completed
CompareCT.gov

A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Mar 17, 2015·Updated Dec 6, 2017

In Brief

A Phase 3 clinical trial evaluating Lumacaftor and Ivacaftor for Cystic Fibrosis and Advanced Lung Disease. Completed, enrolled 46 participants across 6 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Advanced Lung Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartMar 1, 2015
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.3 years ago

Interventions

Lumacaftordrug

Ivacaftordrug