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RecruitingNCT03773887TargetOHUpdated May 22, 2026

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

An interventional study of collection of liver biopsies collection of blood samples in Liver Diseases and Acute on Chronic Hepatic Failure, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Dec 2014, registered Oct 2018).
  • Started Dec 2014; still recruiting 11 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Liver Diseases
  • Acute on Chronic Hepatic Failure

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03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 450 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • Other
    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

  • Other
    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

  • Other
    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

Interventions

  • Othercollection of liver biopsies collection of blood samples

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

06

What researchers measure

Primary outcomes

  1. the expression of proinflammatory cytokines

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

    Time frame: Baseline

Secondary outcomes

  1. the expression of genetic variants of pro-inflammatory cytokines

    Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease

    Time frame: Baseline

  2. Cell lysis (AST, ALT, CK18 cleaved)

    Time frame: Baseline

  3. Regeneration markers (Ki-67, Fn14, CK7)

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Hôpital Claude Huriez, CHRU
    Lille, France
    • Philippe Mathruin, MD,PhD · Principal investigator
    • Alexandre Louvet, MD,PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03773887
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Dec 12, 2018
Start date
Dec 25, 2014
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
May 22, 2026

Study contacts

Philippe Mathurin, MD,PhD
Contact
philippe.mathurin@chru-lille.fr
03 20 44 55 97 ext. +33
Philppe Mathurin, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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