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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT04781933
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of moderate to severe NASH :
* chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects
* metabolic syndrome
* liver stiffness assessed by FibroScan between 8 and 15kPa
* Adults
* Affiliated to a social security
* Women using effective contraception (hormonal or mechanical) for the duration of the srudy
Exclusion Criteria:
* Pregnancy
* Excessive alcohol consumption (\>100g/week)
* Cirrhosis (elastometry \> 15kPa)
* hepato-cellular carcinoma
* Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
* Viral hepatitis
* Auto immune hepatitis
* anticoagulant therapy
* antibiotics in the month prior to inclusion
* allergic to soya, aspirin, fish, E110 dye, Maltodextrin
* poorly controlled diabetes (Glycated Hemoglobin \>8%)
* inclusion in a drug interventional trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04781933
Study Brief:
Protocol Section:
NCT04781933