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Recruiting Not applicable

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

NCT03773887 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2014-12-25
Last updated
2026-05-22

Condition(s) studied

Liver DiseasesAcute on Chronic Hepatic Failure

Investigational drug(s) / intervention(s)

collection of liver biopsies collection of blood samples

collection of liver biopsies collection of blood samples: blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • the expression of proinflammatory cytokines — Baseline
    Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Claude Huriez, CHRU Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03773887 on ClinicalTrials.gov ↗ ← All trials in France