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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03589820
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of Wilson Disease: serum ceruloplasmin \< 0.2g/L, 24 hours urinary copper \> 40μg, Kayser-Fleischer ring present;
2. Do not receive drugs to promote the excretion of copper ever before;
3. Serum total bilirubin \> 10 times upper limit of normal, prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5.
Exclusion Criteria:
1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03589820
Study Brief:
Protocol Section:
NCT03589820