CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 116 enrolled
Drug / intervention
VX-659/TEZ/IVA +4 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/NCT03460990
NCT03460990Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Vertex Pharmaceuticals Incorporated·interventional·Posted Mar 9, 2018·Updated Oct 17, 2019

In Brief

A Phase 3 clinical trial evaluating VX-659/TEZ/IVA, TEZ/IVA, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 116 participants across 46 sites in 6 countries.

Detailed Summary

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Germany, Ireland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 9, 2018
Enrollment StartMay 1, 2018
Primary CompletionSep 26, 2018
Study CompletionOct 8, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.3 years ago

Interventions

VX-659/TEZ/IVAdrug

Participants received VX-659/TEZ/IVA orally once daily in the morning.

TEZ/IVAdrug

Participants received TEZ/IVA orally once daily in the morning.

IVAdrug

Participants received IVA orally once daily in the evening.

Placebodrug

Participants received placebo matched TEZ/IVA orally once daily in the morning.

Placebodrug

Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.