NCT03773887

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Sep 2015Sep 2027

Study Start

First participant enrolled

September 1, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

12 years

First QC Date

October 16, 2018

Last Update Submit

January 6, 2021

Conditions

Liver DiseasesAcute on Chronic Hepatic Failure

Outcome Measures

Primary Outcomes (1)

  • the expression of proinflammatory cytokines

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

    Baseline

Secondary Outcomes (3)

  • the expression of genetic variants of pro-inflammatory cytokines

    Baseline

  • Cell lysis (AST, ALT, CK18 cleaved)

    Baseline

  • Regeneration markers (Ki-67, Fn14, CK7)

    Baseline

Study Arms (3)

acute alcoholic hepatitis

OTHER

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

Alcoholic cirrhosis

OTHER

collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)

Other: collection of liver biopsies collection of blood samples

Without chronic liver disease

OTHER

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

collection of liver biopsies collection of blood samplesOTHER

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

Alcoholic cirrhosisWithout chronic liver diseaseacute alcoholic hepatitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHRU

Lille, France

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Philppe Mathurin, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Mathurin, MD,PhD

CONTACT

03 20 44 55 97philippe.mathurin@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

December 12, 2018

Study Start

September 1, 2015

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

FR(1)