Summary

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

Description

Summary

This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

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 Homozygous or Heterozygous for the F508del Mutation

Keywords

Cystic Fibrosis Fibrosis Ivacaftor VX-445 TEZ IVA

Eligibility

You can join if…

Open to people ages 12 years and up

  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a 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 drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCSF Gateway Medical Center
    San Francisco California 94143 United States
  • Kaiser Permanente
    Oakland California 94611 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT03525574
Phase
Phase 3
Study Type
Interventional
Last Updated