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NCT Number: NCT03773887

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHRU

Lille, France

Location status: Recruiting

Location contact

Alexandre Louvet, MD,PhD

SUB_INVESTIGATOR

Philippe Mathruin, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of liver biopsies collection of blood samples

Other

blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies

Primary outcomes

  1. the expression of proinflammatory cytokines

    Time frame: Baseline

    Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Mathurin, MD,PhD

CONTACT

[email protected]

03 20 44 55 97 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: TargetOH

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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