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 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
  • Valley Children's Hospital
    Madera California 93636 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT03525574
Phase
Phase 3
Study Type
Interventional
Last Updated