Actively Recruiting
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Led by University Hospital, Lille · Updated on 2021-01-07
450
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 50 mg/l
- Absence of autoimmune liver disease (ANA <1/80, AML <1/80, LKM1 negative, AAM negative)
- Absence of hepatitis B, hepatitis C, and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
- Patients with other acute complications than alcoholic hepatitis may be included (e.g., digestive hemorrhage, acute renal failure, infection)
- Histological confirmation of alcoholic hepatitis required by biopsy showing hepatocellular lesions and inflammatory infiltrate
- Patients with alcoholic cirrhosis (decompensated or non-decompensated) diagnosed by biopsy or clinical/biological criteria
- Patients without chronic liver disease needing blood and liver sampling for other pathology (e.g., liver metastasis of digestive cancer)
You will not qualify if you...
- Patients with hepatocellular carcinoma or progressive non-hepatic cancer
- Presence of HBsAg (hepatitis B surface antigen)
- Presence of anti-HCV antibodies with positive PCR
- Presence of antibodies to HIV 1 and 2
- Pregnancy
- Patients with alcoholic liver disease excluded from the group without chronic liver disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Claude Huriez, CHRU
Lille, France
Actively Recruiting
Research Team
P
Philippe Mathurin, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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