A Study Testing the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy in Cystic Fibrosis

a study on Cystic Fibrosis Fibrosis

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion

Description

Summary

This study evaluated the long-term safety, efficacy, 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 the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

Official Title

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy 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)

Keywords

Cystic Fibrosis, Fibrosis, Ivacaftor, Elexacaftor, ELX/TEZ/IVA, IVA

Eligibility

You can join if…

Open to people ages 12 years and up

  • Completed study drug treatment in parent study (VX18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study

You CAN'T join if...

  • History of study drug intolerance in parent study

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California Davis Medical Center
    Sacramento California 95817 United States
  • University of California San Francisco, Lung Transplant Program
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Vertex Pharmaceuticals Incorporated
Links
Sign up for this study
ID
NCT04058366
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 251 people participating
Last Updated
Contact us about this trial