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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03950804
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with PIL form the study groups and deem eligible for the study unless there is a risk associated with blood draw.
2. The patients with CHAPLE syndrome who receive eculizumab therapy and consent to participate in this study are followed prospectively and clinical data collected. Biological sample collection and molecular investigations are to be made only if the patient is willing to provide biological samples, including peripheral blood and stool.
Exclusion Criteria:
1. Presence of a concomitant disease that leads to hypoproteinemia at the time of starting eculizumab such as a urinary protein loss or a hepatic disease that affects production of proteins by liver.
2. A concomitant disease that leads to secondary intestinal lymphangiectasia such as a fontan procedure for congenital heart disease.
3. Unstable clinical condition not allowing blood draw, such as severe anemia.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT03950804
Study Brief:
Protocol Section:
NCT03950804