Status:
UNKNOWN
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Lead Sponsor:
University Hospital, Lille
Conditions:
Alcoholic Liver Disease
Severe Alcoholic Hepatitis
Eligibility:
All Genders
18+ years
Brief Summary
Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not seve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT04106518
Start Date
October 23 2019
End Date
April 1 2025
Last Update
November 29 2023
Active Locations (9)
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1
Chr Angers
Angers, France
2
Chru Besancon
Besançon, France
3
Hôpital Jean Verdier, AH-HP
Bondy, France
4
Centre Hospitalier Universitaire
Caen, France