CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 113 enrolled
Drug / intervention
VX-445/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/NCT03525548
NCT03525548Phase 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 Homozygous for the F508del Mutation (F/F)

Vertex Pharmaceuticals Incorporated·interventional·Posted May 15, 2018·Updated Jan 27, 2020

In Brief

A Phase 3 clinical trial evaluating VX-445/TEZ/IVA, TEZ/IVA, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 113 participants across 44 sites in 4 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 homozygous for the F508del mutation (F/F)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBelgium, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartAug 3, 2018
Primary CompletionDec 28, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.1 years ago

Interventions

VX-445/TEZ/IVAdrug

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

Placebodrug

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