CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 385 enrolled
Drug / intervention
VX-659/TEZ/IVA +2 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/NCT03447249
NCT03447249Phase 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 Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Vertex Pharmaceuticals Incorporated·interventional·Posted Feb 27, 2018·Updated Mar 13, 2020

In Brief

A Phase 3 clinical trial evaluating VX-659/TEZ/IVA, IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 385 participants across 101 sites in 11 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 heterozygous for F508del and a minimal function mutation (F/MF subjects).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, Denmark, Germany, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartMar 7, 2018
Primary CompletionFeb 5, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.3 years ago

Interventions

VX-659/TEZ/IVAdrug

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

IVAdrug

Participants received IVA orally once daily in the evening.

Placebodrug

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