Summary

for people ages 12 years and up (full criteria)
at Long Beach, California and other locations
study started
estimated completion

Description

Summary

This study will evaluate 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 VX-445 ELX/TEZ/IVA IVA

Eligibility

For people ages 12 years and up

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • History of study drug intolerance in parent study

Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Miller Children's Hospital / Long Beach Memorial
    Long Beach California 90806 United States
  • Oregon Health & Science University
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
Links
Sign up for this study
ID
NCT04058366
Phase
Phase 3
Study Type
Interventional
Last Updated