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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT06152250
Eligibility Criteria:
Inclusion Criteria:
* patient with a clinical diagnosis of NAFLD: steatosis detected on imaging and exclusion of secondary causes of steatosis (drugs, genetics, alcohol consumption \>30 g/d in men and 20 g/d in women, chronic viral infection), in the absence or presence of an associated metabolic syndrome
* and with significant liver fibrosis (≥ F2) on at least one non-invasive test (FibroScan®, Fibrometer®, NAFLD Fibrosis Score);
* Patient of legal age (age ≥ 18 years);
* Patient willing to undergo liver biopsy ;
* Patient consenting to inclusion in the study after being informed and obtaining written consent;
* Patient affiliated to a social security scheme.
Exclusion Criteria:
* Decompensated cirrhosis or clinically significant portal hypertension (clinical, radiological or endoscopic signs of portal hypertension; presence of hepatocellular insufficiency);
* Secondary causes of steatosis, including chronic viral hepatitis, drugs, excessive alcohol consumption according to World Health Organization (WHO) criteria (\> 30 g/d in men and 20 g/d in women), genetic mutations;
* Any other cause of liver disease: genetic hemochromatosis, autoimmune liver disease, etc. (non-exhaustive list);
* Presence of HCC at the time of inclusion;
* Contraindications to liver biopsy (identical to those for FNA): coagulation disorders, biliary tract dilatation, intrahepatic tumor;
* Pregnant, parturient or breast-feeding women;
* Persons deprived of their liberty by judicial or administrative decision;
* adults under legal protection (guardianship, curators).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06152250
Study Brief:
Protocol Section:
NCT06152250