Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease (COMADHAA)
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ClinicalTrials.gov Identifier: NCT04106518 |
Recruitment Status :
Recruiting
First Posted : September 27, 2019
Last Update Posted : November 18, 2020
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Condition or disease |
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Alcoholic Liver Disease Severe Alcoholic Hepatitis Alcoholic Cirrhosis |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 447 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease |
Actual Study Start Date : | October 23, 2019 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Group/Cohort |
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cirrhosis
Patients with alcoholic liver disease without alcoholic hepatitis
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severe alcoholic hepatitis
Patients with severe alcoholic hepatitis ( Maddrey score ≥32)
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non-severe alcoholic hepatitis
Patients with non-severe alcoholic hepatitis (Maddrey score <32)
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- 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
- Survival [ Time Frame: at 12 months ]Survival rate 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
- 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
- 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.
- 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.
- 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.
- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
For SAH group:
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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:
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Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106518
Contact: Alexandre Louvet, MD,PhD | 03 20 44 55 97 ext +33 | alexandre.louvet@chru-lille.fr |
France | |
Chru Besancon | Recruiting |
Besançon, France | |
Hôpital Jean Verdier, AH-HP | Recruiting |
Bondy, France | |
Centre Hospitalier Universitaire | Recruiting |
Caen, France | |
Hôpital Claude Huriez, CHU | Recruiting |
Lille, France | |
Chu Montpellier | Recruiting |
Montpellier, France |
Principal Investigator: | Alexandre Louvet, MD,PhD | University Hospital, Lille |
Responsible Party: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT04106518 |
Other Study ID Numbers: |
2017_51 2018-A02286-49 ( Other Identifier: ID-RCB number, ANSM ) |
First Posted: | September 27, 2019 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cohort alcoholic hepatitis alcoholic cirrhosis |
pathophysiology bio bank pan-genomic study |
Hepatitis A Hepatitis Liver Diseases Hepatitis, Alcoholic Liver Diseases, Alcoholic Liver Cirrhosis, Alcoholic Fibrosis Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Pathologic Processes Liver Cirrhosis Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |