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Recruiting NCT03773887

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

No phase Interventional Liver Diseases Acute on Chronic Hepatic Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: collection of liver biopsies collection of blood samples.
Who it may be relevant to
Registry conditions: Liver Diseases, Acute on Chronic Hepatic Failure. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

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

Primary outcome measures

  • the expression of proinflammatory cytokines [Time frame: Baseline]
Secondary outcome measures (3)
  • the expression of genetic variants of pro-inflammatory cytokines [Time frame: Baseline]
  • Cell lysis (AST, ALT, CK18 cleaved) [Time frame: Baseline]
  • Regeneration markers (Ki-67, Fn14, CK7) [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Hôpital Claude Huriez, CHRU — Lille

Identifiers

NCT: NCT03773887 · 2014_30 · 2014-A01452-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗