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Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease (TargetOH)

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ClinicalTrials.gov Identifier: NCT03773887
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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

Condition or disease Intervention/treatment Phase
Liver Diseases Acute on Chronic Hepatic Failure Other: collection of liver biopsies collection of blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
acute alcoholic hepatitis
collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)
Other: 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)
Other: 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)
Other: collection of liver biopsies collection of blood samples
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies




Primary Outcome Measures :
  1. the expression of proinflammatory cytokines [ Time Frame: Baseline ]
    Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)


Secondary Outcome Measures :
  1. the expression of genetic variants of pro-inflammatory cytokines [ Time Frame: Baseline ]
    Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease

  2. Cell lysis (AST, ALT, CK18 cleaved) [ Time Frame: Baseline ]
  3. Regeneration markers (Ki-67, Fn14, CK7) [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773887


Contacts
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Contact: Philippe Mathurin, MD,PhD 03 20 44 55 97 ext +33 philippe.mathurin@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHRU Recruiting
Lille, France
Principal Investigator: Philippe Mathruin, MD,PhD         
Sub-Investigator: Alexandre Louvet, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Philppe Mathurin, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03773887     History of Changes
Other Study ID Numbers: 2014_30
2014-A01452-45 ( Other Identifier: ID-RCB Number, ANSM )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Liver Failure, Acute
Liver Extracts
Hematinics