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NCT Number: NCT04106518

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

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.

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Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Cirrhosis Chemically-Induced Disorders Digestive System Diseases Fibrosis Hepatitis Hepatitis, Alcoholic Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Alcoholic Hepatitis Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chr Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Survival

    Time frame: at 12 months

    Survival rate at 12 months

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre Louvet, MD,PhD

CONTACT

[email protected]

03 20 44 55 97 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: COMADHAA

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2019
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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