Summary
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants 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
PHASE3
Gender
ALL
Min Age
6 Years
Max Age
N/A
Download Date
2024-04-19
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: