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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02557360
Eligibility Criteria:
Inclusion Criteria:
* primary biliary cirrhosis diagnosed with EASL criteria;
* treatment with UDCA at least 3 months.
Exclusion Criteria:
* overlap syndromes (i.e. autoimmune hepatitis), viral hepatitis;
* decompensated liver cirrhosis (Child-Pugh class B-C);
* other diseases that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure ≥ New York Heart Association (NYHA) II, rheumatoid arthritis, asthma, mood disorders, depression;
* treatment with: steroids, statins, rifampicin, antidepressants.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02557360
Study Brief:
Protocol Section:
NCT02557360