Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT03625466
Eligibility Criteria:
Key Inclusion Criteria:
* Subjects with confirmed diagnosis of CF.
* Homozygous for F508del (F/F).
* Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening Visit.
Key Exclusion Criteria:
* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject.
* Solid organ or hematological transplantation.
* History of any illness or comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study.
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT03625466
Study Brief:
Protocol Section:
NCT03625466