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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02730208
Eligibility Criteria:
Inclusion Criteria:
* Homozygous for the F508del CFTR mutation
* Confirmed diagnosis of CF
* Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age, sex, and height during screening.
* Stable CF disease as judged by the investigator
Exclusion Criteria:
* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to 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 (first dose of study drug)
* Pregnant or nursing females.
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
* Any contraindication to undergoing chest imaging, as per the site's institutional guidelines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02730208
Study Brief:
Protocol Section:
NCT02730208