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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05798702
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent signed before starting any procedure foreseen by the study;
* Liver Ultrasound shoving steatosis and Fibroscan\>9,5 KPa;
* NAFLD fibrosis score\>0,676;
* diagnosis of NASH with stage F3-F4 of fibrosis according to SAF score, documented by liver biopsy and no evidence of another form of liver disease;
* BMI≥ 30 and ≤50 kg/m2;
* Age 25-65 years.
Exclusion Criteria:
* Chronic liver disease other than NAFLD (e.g. hemochromatosis, viral or autoimmune hepatitis, Wilson's disease, α1 -antitrypsin deficiency);
* Presence of esophageal varices and/or ascites;
* INR ≥ 1,4;
* Platelet count ≤ 100000;
* Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men) and/or toxin exposure;
* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months;
* End stage renal failure;
* Participation in any other concurrent therapeutic clinical trial;
* Any other life-threatening, non-cardiac disease;
* Pregnancy;
* Type 1 diabetes, or LADA;
* Lipodystrophy;
* Abetalipoproteinemia;
* Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids);
* Inability to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05798702
Study Brief:
Protocol Section:
NCT05798702