Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease (TargetOH)

University Hospital, Lille

Status: Enrolling

Conditions: Acute on Chronic Hepatic Failure; Liver Diseases

Treatments: Other: collection of liver biopsies collection of blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03773887

2014_30

2014-A01452-45 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• group A: patients with acute alcoholic hepatitis
• Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women)
• Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
• Bilirubin> 50 mg / l
• Absence of autoimmune liver disease (ANA <1/80, AML <1/80, LKM1 neg, AAM neg)
• Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
• Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)
• Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)/ Inflammatory infiltrate with polymorphonuclear neutrophils
• group B1: patients with alcoholic cirrhosis
• Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)
• group B2: patients free from chronic liver disease
• Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)

Exclusion criteria

• For groups A and B1:
• Patients with hepatocellular carcinoma of progressive non-hepatic cancer
• Presence of HBsAg
• Presence of anti-HCV antibodies by positive PCR
• Presence of antibodies to HIV 1 +2
• Pregnancy
• for group B2:
• Alcoholic liver disease
• Presence of HBsAg
• Presence of anti-HCV antibodies by positive PCR
• Presence of antibodies to HIV 1 +2
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

acute alcoholic hepatitis

Other group

Description:

collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)

Treatment:

Other: collection of liver biopsies collection of blood samples

Alcoholic cirrhosis

Other group

Description:

collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)

Treatment:

Other: collection of liver biopsies collection of blood samples

Without chronic liver disease

Other group

Description:

collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)

Treatment:

Other: collection of liver biopsies collection of blood samples