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

May 18, 2026 updated by: University Hospital, Lille
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Chr Angers
      • Besançon, France
        • Recruiting
        • CHRU Besançon
      • Bondy, France
        • Recruiting
        • Hôpital Jean Verdier, AH-HP
      • Caen, France
        • Recruiting
        • Centre Hospitalier Universitaire
      • La Tronche, France
        • Recruiting
        • Hopital Nord - Chu38 - La Tronche
      • Lille, France
        • Recruiting
        • Hôpital Claude Huriez, CHU
      • Marseille, France
        • Recruiting
        • Association Hopital Saint Joseph - Marseille
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
      • Paris, France
        • Recruiting
        • Hu Est Parisien Site St Antoine Aphp - Paris 12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to jaundice will receive a liver biopsy in accordance with the usual management for diagnosis of alcoholic hepatitis, according to the recommendations of the European Association of Liver Diseases (EASL).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
cirrhosis
Patients with alcoholic liver disease without alcoholic hepatitis
severe alcoholic hepatitis
Patients with severe alcoholic hepatitis ( Maddrey score ≥32)
non-severe alcoholic hepatitis
Patients with non-severe alcoholic hepatitis (Maddrey score <32)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
Time Frame: At baseline (time of liver biopsy)
Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice
At baseline (time of liver biopsy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: at 12 months
Survival rate at 12 months
at 12 months
Change in serum total bilirubin
Time Frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Change in serum creatinine
Time Frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Change in MELD (Model for End-stage Liver Disease)score
Time Frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
The MELD score is a validated tool based on INR, creatinine and bilirubin measured in the blood with the following formula:(9.57 × log creatinine in milligrams per deciliter) + (3.78 × log bilirubin in milligrams per deciliter) + (11.20 × log international normalized ratio) + 6.43. The MELD score is used in liver disorders to assess the degree of liver failure. It has no unit.
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Identification of inflammatory and biochemical profiles of patients with severe, non-severe and cirrhotic alcoholic hepatitis, based on the constitution of a biobank (serum and plasma)
Time Frame: Baseline, at 7 days, at 30 days and at 12 months
Serum and plasma evaluation of translational markers (e.g. cytokines) associated with inflammation in patients with alcohol-related liver disease. The list of markers which will be assessed cannot be determined at present and will depend on other ongoing studies performed in alcoholic hepatitis.
Baseline, at 7 days, at 30 days and at 12 months
Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample)
Time Frame: Baseline
Evaluation of genetic markers associated with alcoholic hepatitis as compared to patients with alcohol-related liver disease without alcoholic hepatitis. We will use a non a priori approach as recommended in genetic studies. Thus, the list of genetic markers cannot be provided at that time.
Baseline
Measurement of diagnostic performance (area under the ROC curve)
Time Frame: At baseline
Measurement of diagnostic performance (area under the ROC curve) of the simple and non-invasive clinical and biological criteria for alcoholic hepatitis proposed in an international expert opinion
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Alexandre Louvet, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2019

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_51
  • 2018-A02286-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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