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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02690857
Eligibility Criteria:
Inclusion Criteria:
* Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \> 60 mmol/L and a pancreatic insufficiency.
* Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
* Body weight \> 26 kg
* Stable CF disease as judged by the investigator.
* Subjects must have an Forced Expiratory Volume at one second \> 40 % of predicted normal for age, sex and height at the screening visit.
* Subjects should not have enteral or parenteral nutrition.
* No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.
Exclusion Criteria:
* Subjects with cirrhosis and portal hypertension.
* Subjects with Cystic fibrosis related diabetes.
* Concomitant participation in another clinical study.
* Known allergy or intolerance to the active principle.
* Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
* Subjects on a transplant waiting list.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT02690857
Study Brief:
Protocol Section:
NCT02690857