Protective Immune Mechanisms in Alcoholic Hepatitis

Completed

• Conditions: Alcoholic Hepatitis

• Registration Number: NCT01918462
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.

Detailed Description

The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Status Verified: 2018-10
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Diagnosis of alcoholic hepatitis:
• relevant history of alcohol consumption (>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
• bilirubin > 80 mol/l
• neutrophil granulocytes > 10x10^9/L
• exclusion of other liver pathology including biliary disease
• histological verification on liver biopsy
• Written, informed consent

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Exclusion Criteria

• Other chronic inflammatory or autoimmune diseases
• Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
• Cancer
• Prednisolon or pentoxifylline treatment within the past 8 weeks
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of IL-22-producing cells	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.

Secondary Outcome Measures

Name	Time	Method
IL-22 binding protein	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.
IL-22 receptor	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.
Signalling molecules and markers of hepatocyte destruction	at day 1, at day 7 and at day 90 after diagnosis.	Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 90 after diagnosis.

Trial Locations

Locations (1)

Department of Hepatology and gastroenterology V, Aarhus university hospital; 🇩🇰 Aarhus, Denmark