CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 271 enrolled
Drug / intervention
ELX/TEZ/IVA +2 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Confirmed cystic fibrosis diagnosis with heterozygous F508del and either a gating or residual function mutation (F/G or F/RF genotype)
  • ✓FEV1 40–90% of predicted normal for age, sex, and height
Key exclusion· 3
  • ✕Clinically significant cirrhosis with or without portal hypertension
  • ✕Lung infection with organisms associated with more rapid decline in pulmonary function
  • ✕Prior solid organ or hematological transplantation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058353
NCT04058353Phase 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 Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Vertex Pharmaceuticals Incorporated·interventional·Posted Aug 15, 2019·Updated Jul 2, 2021

In Brief

A Phase 3 clinical trial evaluating ELX/TEZ/IVA, IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 271 participants across 93 sites in 13 countries.

Detailed Summary

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, 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 gating or residual function mutation (F/G and F/RF genotypes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartAug 28, 2019
Primary CompletionJun 12, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.9 years ago

Interventions

ELX/TEZ/IVAdrug

FDC tablet for oral administration.

IVAdrug

Mono-tablet for oral administration.

TEZ/IVAdrug

Fixed-dose combination (FDC) tablet for oral administration.