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Search / Trial NCT03773887

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Launched by UNIVERSITY HOSPITAL, LILLE · Dec 11, 2018

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the differences in inflammation and healing potential between patients with alcoholic hepatitis and those with alcoholic cirrhosis, as well as people without liver disease. The goal is to understand how inflammation affects these conditions and to identify potential ways to improve treatment.

To participate, you must be between 18 and 80 years old and meet specific health criteria. For example, if you have alcoholic hepatitis, you need to have a history of significant alcohol consumption and certain liver test results. Patients with alcoholic cirrhosis or those without chronic liver disease can also take part if they meet the study's requirements. If you join the trial, you can expect to undergo tests to confirm your condition, and your health will be closely monitored. This research is important as it may help improve the understanding and treatment of liver diseases related to alcohol use.

Gender

ALL

Eligibility criteria

  • 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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Lille, , France

Patients applied

0 patients applied

Trial Officials

Philppe Mathurin, MD,PhD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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