Health TrialsbyHealthPanel

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

ConditionsLiver DiseasesAcute on Chronic Hepatic Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • collection of liver biopsies collection of blood samples

    Other intervention

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

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: acute alcoholic hepatitisOther 1 intervention
Group B: Alcoholic cirrhosisOther 1 intervention
Group C: Without chronic liver diseaseOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov
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