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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT02723968
Eligibility Criteria:
Inclusion Criteria:
* Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \> 60 mmol/L.
* Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation.
* Subjects will be pancreatic insufficient.
* Subjects must have a forced expiratory volume 1 (FEV1)\> 40 % of predicted normal for age, sex and height at the screening visit.
* Stable CF disease as judged by the investigator
Exclusion Criteria:
* Subjects with glucose intolerance abnormalities
* Subjects with pulmonary exacerbation within 4 weeks before screening
* History of lung or hepatic transplantation or awaiting transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT02723968
Study Brief:
Protocol Section:
NCT02723968