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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Acute on Chronic Hepatic Failure
• Intervention / Treatment: Other: collection of liver biopsies collection of blood samples

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Mathurin, MD,PhD; Phone Number: +33 03 20 44 55 97; Email: philippe.mathurin@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Claude Huriez, CHRU
    • Principal Investigator: Philippe Mathruin, MD,PhD
    • Sub-Investigator: Alexandre Louvet, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: acute alcoholic hepatitis; collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)	Other: collection of liver biopsies collection of blood samples; blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Other: Alcoholic cirrhosis; collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)	Other: collection of liver biopsies collection of blood samples; blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Other: Without chronic liver disease; collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)	Other: collection of liver biopsies collection of blood samples; blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the expression of proinflammatory cytokines	Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philppe Mathurin, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2014
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 2014_30; 2014-A01452-45 (Other Identifier: ID-RCB Number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No