Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Alcoholic Liver Disease
    Severe Alcoholic Hepatitis
    Alcoholic Cirrhosis

NCT04106518

University Hospital, Lille

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.