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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06159257
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented steatohepatitis (NASH) with at least minimal (grade 1) hepatocyte ballooning and inflammation on a biopsy performed in the past year.
* OR, if a biopsy is not available:
1. Presence of metabolic risk factors (see below) AND
2. Documentation of steatosis on imaging (hepatic ultrasound, CT scan or MRI) AND
3. Increased ALT \>30 IU/L OR liver stiffness \>5 kPa on Fibroscan
* Metabolically stable condition, in particular no weight change \>5% in the past 6 months, anticipated stable diabetic therapy during the study period
* No other identifiable cause of liver disease
* Patients affiliated to French social security.
* Written informed consent signed by the patient
Exclusion Criteria:
* Patient with Hepatitis B or C.
* Presence of any other form of chronic liver disease
* Average alcohol consumption greater than 20 g/day for females and 30 g/day for males in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
* Severely uncontrolled diabetes (HbA1c\>9.5%)
* Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
* Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
* HIV infection.
* Person not fasted 12 hours (T10, T12, D0).
* Substantial diet modification in the 4 months prior to inclusion.
* Patients judged by the investigator to be unsuitable for inclusion in the study (e.g., judged by the physician as unlikely to be compliant with the study protocol).
* Pregnant or breastfeeding women.
* Patient under legal protection measure.
* Patient is a participating in another research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT06159257
Study Brief:
Protocol Section:
NCT06159257