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

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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)

Locations
Other Locations
France
Chr Angers
RECRUITING
Angers
Chru Besancon
RECRUITING
Besançon
Hôpital Jean Verdier, AH-HP
RECRUITING
Bondy
Centre Hospitalier Universitaire
RECRUITING
Caen
Hopital Nord - Chu38 - La Tronche
RECRUITING
La Tronche
Hôpital Claude Huriez, CHU
RECRUITING
Lille
Association Hopital Saint Joseph - Marseille
RECRUITING
Marseille
Chu Montpellier
RECRUITING
Montpellier
Hu Est Parisien Site St Antoine Aphp - Paris 12
RECRUITING
Paris
Contact Information
Primary
Alexandre Louvet, MD,PhD
alexandre.louvet@chru-lille.fr
03 20 44 55 97
Time Frame
Start Date: 2019-10-23
Estimated Completion Date: 2025-04
Participants
Target number of participants: 447
Treatments
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)
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov