Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Not Applicable

Recruiting

• Conditions: Liver Diseases; Acute on Chronic Hepatic Failure

• Registration Number: NCT03773887
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the expression of proinflammatory cytokines	Baseline	Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)

Secondary Outcome Measures

Name	Time	Method
Cell lysis (AST, ALT, CK18 cleaved)	Baseline
the expression of genetic variants of pro-inflammatory cytokines	Baseline	Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease
Regeneration markers (Ki-67, Fn14, CK7)	Baseline

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHRU; 🇫🇷 Lille, France