Comparing inflammatory profiles in alcoholic liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the inflammatory profiles of patients with acute alcoholic hepatitis to those with alcoholic cirrhosis and healthy individuals with chronic liver disease. It involves collecting liver biopsies and blood samples to analyze pro-inflammatory cytokines. The goal is to better understand the regenerative potential and inflammatory responses in these different patient groups. This could provide insights into the pathophysiology of alcoholic liver disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Claude Huriez, CHRU
  Lille, France Recruiting

Study contacts

• Principal investigator: Philppe Mathurin, MD,PhD — University Hospital, Lille
• Study coordinator: Philippe Mathurin, MD,PhD
• Email: philippe.mathurin@chru-lille.fr
• Phone: 03 20 44 55 97

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Everolimus-based calcineurin-free immunosuppression one year after liver transplant

  This trial tests whether switching to or using everolimus with reduced calcineurin inhibitors after year one post-liver transplant can protect kidney function while maintaining graft health in adults at low rejection risk.

  Recruiting Phase 3 Hannover Medical School · Heidelberg, Baden-Wurttemberg and 15 other locations · NCT07739914

• Metastatic liver cancer patient registry from multiple Chinese centers

  This is a registry that collects real-world data on adults with liver metastases to understand patterns and prognosis and to support future research.

  Recruiting at 2 sites Anhui Provincial Hospital · Bengbu, Anhui and 2 other locations · NCT07602504

• Safety and how the drug behaves in adults with moderate to severe liver impairment

  This study tests the safety and how INCB123667 moves through the body when taken by adults with moderate to severe liver impairment.

  Recruiting at 4 sites Phase 1 Incyte Corporation · Chandler, Arizona and 3 other locations · NCT07559474

• Single-probe FibroScan for measuring liver stiffness

  This project will try a single-probe FibroScan to measure liver stiffness in adults with chronic liver disease and compare its results to the standard M and XL probes.

  Recruiting Echosens · Besançon and 3 other locations · NCT07400289

• Using polyene phosphatidylcholine to protect the liver after hepatectomy

  This test checks whether giving polyene phosphatidylcholine before surgery plus magnesium isoglycyrrhizinate after surgery better prevents liver injury in people having laparoscopic liver resection for hepatocellular carcinoma.

  Recruiting Phase 4 Anhui Provincial Hospital · Hefei, Anhui · NCT07150624

• CRISPR-edited donor liver transplant to reduce rejection

  This trial will try transplanting deceased-donor livers that have had key HLA genes removed with CRISPR to see if they cause less rejection in adults needing a liver transplant.

  Recruiting Phase 1/2 American Organ Transplant and Cancer Research Institute LLC · Beijing, Changping · NCT07053488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.