CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 225 enrolled
Drug / intervention
IVA +6 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/NCT03227471
NCT03227471Phase 2Completed
CompareCT.gov

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated·interventional·Posted Jul 24, 2017·Updated Jan 18, 2022

In Brief

A Phase 2 clinical trial evaluating IVA, TEZ/IVA, and 4 other interventions for Cystic Fibrosis. Completed, enrolled 225 participants across 38 sites in 4 countries.

Detailed Summary

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartJan 23, 2017
Primary CompletionMar 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.9 years ago

Interventions

IVAdrug

IVA tablet for oral administration

TEZ/IVAdrug

TEZ/IVA fixed-dose combination for oral administration.

VX-445drug

VX-445 tablet for oral administration.

Matched Placebodrug

Matched placebo.

TEZdrug

Tablet for oral administration.

VX-561drug

Tablet for oral administration.

VX-445drug

VX-445 IV injection