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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT05785793
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 14 years
* Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria
* Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count
* Provide informed consent
Exclusion Criteria:
* Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis
* Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus
* Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH
* Considered ineligible to the enrollment in the clinical study by the researcher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT05785793
Study Brief:
Protocol Section:
NCT05785793