At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 246 enrolled

Drug / intervention

LUM/IVA +1 moredrug

Likely dose

LUM/IVA 200 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/NCT02544451

NCT02544451Phase 3Completed

Compare CT.gov

A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Sep 9, 2015·Updated May 24, 2021

In Brief

A Phase 3 clinical trial evaluating LUM/IVA for Cystic Fibrosis. Completed, enrolled 246 participants across 60 sites in 9 countries.

Detailed Summary

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCystic Fibrosis

CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Sweden, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartAug 2015

First PostedSep 2015

Primary CompletionAug 2018

Study CompletionApr 2020

TodayJul 2026

First PostedSep 9, 2015

Enrollment StartAug 1, 2015

Primary CompletionAug 1, 2018

Study CompletionApr 1, 2020

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 10.8 years ago

Interventions

LUM/IVAdrug

Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age). LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older).

LUM/IVAdrug

LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).