Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Liver Diseases Clinical Trial

— TargetOH  

Official title:

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773887
• Other study ID #: 2014_30
• Secondary ID: 2014-A01452-45
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2027

Study information

• Verified date: January 2021
• Source: University Hospital, Lille
• Contact: Philippe Mathurin, MD,PhD
• Phone: 03 20 44 55 97
• Email: philippe.mathurin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute on Chronic Hepatic Failure
• Hepatic Insufficiency
• Liver Diseases
• Liver Diseases, Alcoholic
• Liver Failure

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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