Informations générales (source: ClinicalTrials.gov)
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease (TargetOH)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
septembre 2015
septembre 2027
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHRU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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)
- 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)
- 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