Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

Last updated: November 28, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT04106518
2017_51
2018-A02286-49
  • Ages > 18
  • All Genders

Study 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 severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.

Eligibility Criteria

Inclusion

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 portalhypertension) and / or

  • biological signs (increased INR, thrombocytopenia) and / or

  • endoscopic signs (oesophageal / gastric varices)

Exclusion

Exclusion Criteria: For NAH and NSAH groups:

  • Presence of another hepatic pathology: evidenced by blood biology, imaging orhistology (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 histologicalcriteria) in particular absence of jaundice episode
  • Presence of another hepatic pathology: evidenced by blood biology, imaging orhistology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
  • Presence of hepatocellular carcinoma
  • HIV infection

Study Design

Total Participants: 447
Study Start date:
October 23, 2019
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Chr Angers

    Angers,
    France

    Active - Recruiting

  • Chru Besancon

    Besançon,
    France

    Active - Recruiting

  • Hôpital Jean Verdier, AH-HP

    Bondy,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire

    Caen,
    France

    Active - Recruiting

  • Hopital Nord - Chu38 - La Tronche

    La Tronche,
    France

    Active - Recruiting

  • Hôpital Claude Huriez, CHU

    Lille,
    France

    Active - Recruiting

  • Association Hopital Saint Joseph - Marseille

    Marseille,
    France

    Active - Recruiting

  • Chu Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Hu Est Parisien Site St Antoine Aphp - Paris 12

    Paris,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.