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Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03773887
Acronym
TargetOH
Enrollment
450
Registered
2018-12-12
Start date
2014-12-25
Completion date
2027-09-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Hepatic Failure, Liver Diseases

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

Interventions

OTHERcollection of liver biopsies collection of blood samples

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
the expression of proinflammatory cytokinesBaselineProinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)

Secondary

MeasureTime frameDescription
the expression of genetic variants of pro-inflammatory cytokinesBaselineIdentification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease
Cell lysis (AST, ALT, CK18 cleaved)Baseline
Regeneration markers (Ki-67, Fn14, CK7)Baseline

Countries

France

Contacts

CONTACTPhilippe Mathurin, MD,PhD
philippe.mathurin@chru-lille.fr03 20 44 55 97
PRINCIPAL_INVESTIGATORPhilppe Mathurin, MD,PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026