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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT06537466
Eligibility Criteria:
Inclusion Criteria:
1. Patients older than 18 years
2. Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and/or fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.
3. Informed consent form obtained before any trial-related ac.vity.
Exclusion Criteria:
1. Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \<1:160), . .
2. MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively.
3. History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention.
4. Recent significant weight loss ( \> 5 % within previous 6 months)
5. Presence of large esophageal varices (F2 or F3)
6. Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis.
7. Be pregnant or breasxeeding.
8. Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\<30 ml/min).
9. Therapy with SGLT-2 inhibitors and/or GLP-1 agonist started within 6 months of screening visit.
10. Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)
11. Any additional condition that might interfere with optimal participation in the study, according to investigators opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06537466
Study Brief:
Protocol Section:
NCT06537466