NCT04106518 Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
| NCT ID | NCT04106518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Alcoholic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 447 participants |
| Start Date | 2019-10-23 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 447 participants in total. It began in 2019-10-23 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Alexandre Louvet, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04106518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcoholic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04106518 currently recruiting?
Yes, NCT04106518 is actively recruiting participants. Contact the research team at alexandre.louvet@chru-lille.fr for enrollment information.
Where is the NCT04106518 trial being conducted?
This trial is being conducted at Angers, France, Besançon, France, Bondy, France, Caen, France and 5 additional locations.
Who is sponsoring the NCT04106518 clinical trial?
NCT04106518 is sponsored by University Hospital, Lille. The principal investigator is Alexandre Louvet, MD,PhD at University Hospital, Lille. The trial plans to enroll 447 participants.