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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.

Conditions

Cystic Fibrosis

Recruitment Status

Active, not recruiting

Eligibility 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.

Intervention

Intervention Type

Intervention Name

Drug

TEZ/IVA

Drug

IVA

Phase

Phase 3

Gender

All

Min Age

6 Years

Max Age

N/A

Download Date

November 26, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: