RecruitingNot Applicable

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

France447 participantsStarted 2019-10-23

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of alcoholic hepatitis in heavy drinkers with jaundice

Timeframe: At baseline (time of liver biopsy)

Trial details

NCT IDNCT04106518

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Alexandre Louvet, MD,PhD

03 20 44 55 97 alexandre.louvet@chru-lille.fr

View on ClinicalTrials.gov More Alcoholic Liver Disease trials