Comparing inflammatory profiles in alcoholic liver disease
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
This study is trying to see how inflammation works in people with different stages of alcoholic liver disease compared to healthy individuals to better understand the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT03773887 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the inflammatory profiles of patients with acute alcoholic hepatitis to those with alcoholic cirrhosis and healthy individuals with chronic liver disease. It involves collecting liver biopsies and blood samples to analyze pro-inflammatory cytokines. The goal is to better understand the regenerative potential and inflammatory responses in these different patient groups. This could provide insights into the pathophysiology of alcoholic liver disease.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with acute alcoholic hepatitis who meet specific inclusion criteria regarding alcohol consumption and liver function.
Not a fit: Patients with autoimmune liver diseases or those with hepatitis B, C, or HIV infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for patients suffering from alcoholic liver disease.
How similar studies have performed: While there have been studies on inflammatory profiles in liver diseases, this specific comparison in alcoholic liver disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- Hôpital Claude Huriez, CHRU — Lille, France (Recruiting)
Study contacts
- Principal investigator: Philppe Mathurin, MD,PhD — University Hospital, Lille
- Study coordinator: Philippe Mathurin, MD,PhD
- Email: philippe.mathurin@chru-lille.fr
- Phone: 03 20 44 55 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.