A Phase 3 Open-label Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older Homozygous or Heterozygous for the F508del-CFTR Mutation

Study Overview

The purpose of this study is to evaluate the long-term safety and tolerability of TEZ/IVA in subjects with cystic fibrosis aged 6 years and older, who are homozygous or heterozygous for F508del mutation.

Study Description

The purpose of this study is to evaluate the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

Additional Information

Participants will not be paid for their participation.


  • IRB Number: 1802366632
  • Research Study Identifier: TX9368
  • Principal Investigator: Clement Ren, MD

Recruitment Status

Open

Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Registry

Create your profile and be matched to research opportunities

Register Now!

If you need assistance finding a study or if you have any questions, please email: ctsirro@iu.edu or call us at (317) 278-2176