Clinical trial NCT03773887: Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Official title: Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Acute on Chronic Hepatic Failure
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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

Primary outcomes:
measure: the expression of proinflammatory cytokines
timeFrame: Baseline
Secondary outcomes:
measure: the expression of genetic variants of pro-inflammatory cytokines
timeFrame: Baseline
measure: Cell lysis (AST, ALT, CK18 cleaved)
timeFrame: Baseline
measure: Regeneration markers (Ki-67, Fn14, CK7)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Philppe Mathurin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: