CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,131 enrolled
Drug / intervention
TEZ/IVA +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/NCT02565914
NCT02565914Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Oct 1, 2015·Updated Sep 28, 2023

In Brief

A Phase 3 clinical trial evaluating TEZ/IVA and IVA for Cystic Fibrosis. Completed, enrolled 1,131 participants across 154 sites in 16 countries.

Detailed Summary

This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2019
Study CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.8 years ago

Interventions

TEZ/IVAdrug

Fixed dose tablet for oral administration.

IVAdrug

Tablet for oral administration.