A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ivacaftor

Criteria

Inclusion Criteria:

• Completed the Week 24 Visit in Study 113 Part B or the Week 8 Visit in Study 115.

• Eligible CFTR Mutation.

Exclusion Criteria:

• Pregnant and nursing females.

• History of poor compliance with study drug and/or procedures in a previous study as deemed by the investigator.

• Ongoing participation in another study with investigational drug.

Other protocol defined Inclusion/Exclusion criteria may apply.