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 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT04106518
Eligibility Criteria:
Inclusion Criteria:
For SAH group:
* Alcohol consumption :
* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years
* Recent jaundice episode (less than 3 months)
* Bilirubin\> 50 mg / l (85μmol / l)
For NSAH group:
\- Alcohol consumption :
* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years
For cirrhosis (control) group:
* Alcohol consumption :
* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years
* Unambiguous presence of cirrhosis criteria, including:
* clinical signs (ascites, stellar angiomas ...) and / or
* radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or portal hypertension) and / or
* biological signs (increased INR, thrombocytopenia) and / or
* endoscopic signs (oesophageal / gastric varices)
Exclusion Criteria:
For NAH and NSAH groups:
* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection
For cirrhosis (control) group:
* History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode
* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04106518
Study Brief:
Protocol Section:
NCT04106518