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
Completed
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 13, 2023
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: