Liver Diseases Clinical Trial
— TargetOHOfficial title:
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
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
Status | Recruiting |
Enrollment | 450 |
Est. completion date | September 2027 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Claude Huriez, CHRU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the expression of proinflammatory cytokines | Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8) | Baseline | |
Secondary | the expression of genetic variants of pro-inflammatory cytokines | Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease | Baseline | |
Secondary | Cell lysis (AST, ALT, CK18 cleaved) | Baseline | ||
Secondary | Regeneration markers (Ki-67, Fn14, CK7) | Baseline |
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