Alcoholic Liver DiseaseCOMADHAANCT04106518
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
An observational study of Alcoholic Liver Disease and Severe Alcoholic Hepatitis, run by University Hospital, Lille at 9 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Liver Disease, Severe Alcoholic Hepatitis, Alcoholic Cirrhosis
- How many people
- 447 participants
- Where
- 9 sitesFrance
- Study dates
- 23 Oct 2019to Apr 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Chr Angers
Angers
- Recruiting
Chru Besancon
Besançon
- Recruiting
Hôpital Jean Verdier, AH-HP
Bondy
- Recruiting
Centre Hospitalier Universitaire
Caen
- Recruiting
Hopital Nord - Chu38 - La Tronche
La Tronche
- Recruiting
Hôpital Claude Huriez, CHU
Lille
- Recruiting
Association Hopital Saint Joseph - Marseille
Marseille
- Recruiting
Chu Montpellier
Montpellier
- Recruiting
Hu Est Parisien Site St Antoine Aphp - Paris 12
Paris
About this study
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.
- Keywords
- Cohort, alcoholic hepatitis, alcoholic cirrhosis, pathophysiology, bio bank, pan-genomic study
- Medical subject headings
- Liver Diseases, Alcoholic, Hepatitis, Alcoholic, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice
Measured: At baseline (time of liver biopsy)
Secondary outcomes (7)
Survival
Survival rate at 12 months
Measured: at 12 months
Change in serum total bilirubin
Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum
Measured: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Change in serum creatinine
Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline
Measurement of diagnostic performance (area under the ROC curve)
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start23 Oct 2019
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 447 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Louvet, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106518
- Sponsor's protocol ID
- 2017_51
- Other IDs
- 2018-A02286-49
- Acronym
- COMADHAA
- Status last verified
- May 2026
- First submitted
- 27 Jun 2019
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT04106518
- Acronym / sponsor ID
- COMADHAA / 2017_51
- Keywords
- Cohort, alcoholic hepatitis, alcoholic cirrhosis, pathophysiology, bio bank, pan-genomic study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 447 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (19 listed)
- Alcohol consumption :
- Recent jaundice episode (less than 3 months)
- Bilirubin> 50 mg / l (85μmol / l)
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
Key exclusion criteria (9 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Survival
Time frame: 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
Change in serum creatinine
Time frame: 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
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
Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample)
Time frame: Baseline
Measurement of diagnostic performance (area under the ROC curve)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Louvet, MD,PhD principal investigator
University Hospital, Lille
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease and Severe Alcoholic Hepatitis, run by University Hospital, Lille at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Louvet, MD,PhD (03 20 44 55 97 ext. +33, alexandre.louvet@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of alcoholic hepatitis in heavy drinkers with jaundice (time frame: At baseline (time of liver biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.