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Search / Trial NCT04106518

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

Launched by UNIVERSITY HOSPITAL, LILLE · Sep 24, 2019

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Cohort Alcoholic Hepatitis Alcoholic Cirrhosis Pathophysiology Bio Bank Pan Genomic Study

ClinConnect Summary

This clinical trial is studying alcoholic liver disease, particularly a serious condition known as alcoholic hepatitis. The goal is to understand how common this condition is among patients who are hospitalized for jaundice (a yellowing of the skin and eyes) and to see how the severity of the disease affects patient outcomes, like survival rates and liver function. Researchers will also collect genetic samples to learn more about how inflammation and liver regeneration work in these patients.

To participate in the study, individuals must be between the ages of 65 and 74 and have a history of heavy alcohol consumption—defined as more than 40 grams per day for women and 50 grams per day for men—for at least five years. They should have experienced jaundice recently and have certain blood test results. Participants will undergo assessments and may contribute to a biobank that helps researchers identify patterns in the disease. It’s important to note that individuals with other liver diseases or conditions like HIV would not be eligible for this study.

Gender

ALL

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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Montpellier, , France

Lille, , France

Besançon, , France

Angers, , France

Bondy, , France

Caen, , France

La Tronche, , France

Marseille, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Alexandre Louvet, MD,PhD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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