CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
VX-445/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/NCT03525444
NCT03525444Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 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 May 15, 2018·Updated May 19, 2020

In Brief

A Phase 3 clinical trial evaluating VX-445/TEZ/IVA, IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 405 participants across 115 sites in 13 countries.

Detailed Summary

This study will evaluate the efficacy of VX-445 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, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartJun 15, 2018
Primary CompletionApr 24, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.1 years ago

Interventions

VX-445/TEZ/IVAdrug

Participants received VX-445/TEZ/IVA orally once daily in the morning.

IVAdrug

Participants received IVA orally once daily in the evening

Placebodrug

Participants received placebo matched VX-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.