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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT04977661
Eligibility Criteria:
Inclusion Criteria:
* Patients were enrolled in the study
1. if they are \> 18 years old
2. had evidence for NASH; persistently elevated alanine aminotransferase (ALT) \>1.5 times the upper limit of normal)
3. imaging (ultrasound) showing fatty infiltration, and histological evidence of NASH after biopsy (macrovascular steatosis, ballooning degeneration of hepatocytes, scattered lobular inflammation and apoptotic bodies).
Exclusion Criteria:
* Patients were ruled out if they had
1. history of alcohol dependence
2. treatment with drugs known to induce NASH (e.g. amiodarone, calcium channel blocker, tamoxifen, oral anticoagulation, methotrexate , steroids and estrogen)
3. positive serologic markers for known chronic liver diseases (hepatitis B surface antigen, anti-hepatitis C virus antibody antinuclear antibody)
4. human immunodeficiency virus (HIV) infection
5. Diabetes
6. decompensated liver disease defined as serum bilirubin level \>1 mg/dL, albumin level ˂3.5 g/dL, and international normalized ratio (INR) ≥1.7.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04977661
Study Brief:
Protocol Section:
NCT04977661