CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Ivacaftordrug
Likely dose
Ivacaftor 150 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/NCT01707290
NCT01707290Phase 3Completed
CompareCT.gov

A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Oct 16, 2012·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating Ivacaftor for Cystic Fibrosis. Completed, enrolled 125 participants across 38 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBelgium, France, United Kingdom, United States
CollaboratorsCystic Fibrosis Foundation

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2012
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.7 years ago

Interventions

Ivacaftordrug

150 mg tablet, oral use, every 12 hours (q12h)