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

NCT04106518 | Unknown

• 2 other identifiers: 2017_512018-A02286-49
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 9

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.

Conditions

Alcoholic Liver Disease; Severe Alcoholic Hepatitis; Alcoholic Cirrhosis

Keywords

Cohort; alcoholic hepatitis; alcoholic cirrhosis; pathophysiology; bio bank; pan-genomic study

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline (time of liver biopsy)

Secondary Outcomes (7)

• Survival

  at 12 months

• Change in serum total bilirubin

  Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months

• Change in serum creatinine

  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

  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)

  Baseline, at 7 days, at 30 days and at 12 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (9)

Chr Angers

Angers, France

RECRUITING

Chru Besancon

Besançon, France

RECRUITING

Hôpital Jean Verdier, AH-HP

Bondy, France

RECRUITING

Centre Hospitalier Universitaire

Caen, France

RECRUITING

Hopital Nord - Chu38 - La Tronche

La Tronche, France

RECRUITING

Hôpital Claude Huriez, CHU

Lille, France

RECRUITING

Association Hopital Saint Joseph - Marseille

Marseille, France

RECRUITING

Chu Montpellier

Montpellier, France

RECRUITING

Hu Est Parisien Site St Antoine Aphp - Paris 12

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Hepatitis, Alcoholic; Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Hepatitis; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre Louvet, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Louvet, MD,PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: September 27, 2019
• Study Start: October 23, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (9)