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 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT02797132
Eligibility Criteria:
Inclusion Criteria:
* Subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the Screening Visit
* Subjects with confirmed diagnosis of CF at the Screening Visit
* Subjects who are homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation
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
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
* A standard 12-lead ECG demonstrating QTc \>450 millisecond (msec) at the Screening Visit.
* History of solid organ or hematological transplantation.
* Ongoing or prior participation in an investigational drug study (including studies investigating LUM and/or IVA) within 30 days of the Screening Visit.
* History of cataract/lens opacity or evidence of cataract/lens opacity determined to be clinically significant by a licensed ophthalmologist during the ophthalmologic examination at the Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT02797132
Study Brief:
Protocol Section:
NCT02797132