Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
NCT ID: NCT03773887
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2015-09-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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acute alcoholic hepatitis
collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)
collection of liver biopsies collection of blood samples
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Alcoholic cirrhosis
collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)
collection of liver biopsies collection of blood samples
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Without chronic liver disease
collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)
collection of liver biopsies collection of blood samples
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Interventions
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collection of liver biopsies collection of blood samples
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Philppe Mathurin, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Claude Huriez, CHRU
Lille, , France
Countries
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Central Contacts
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Other Identifiers
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2014-A01452-45
Identifier Type: OTHER
Identifier Source: secondary_id
2014_30
Identifier Type: -
Identifier Source: org_study_id
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