Protective Immune Mechanisms in Alcoholic Hepatitis

NCT ID: NCT01918462

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-04-20

Brief Summary

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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

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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.

Conditions

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Alcoholic Hepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alcoholic hepatitis

Patients with alcoholic hepatic; cases.

No interventions assigned to this group

Healthy controls

Persons undergoing hepatic resection; controls.

No interventions assigned to this group

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sidsel Støy, Phd student

Role: PRINCIPAL_INVESTIGATOR

Department of hepatology and gastroenterology, Aarhus University Hospital

Locations

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Department of Hepatology and gastroenterology V, Aarhus university hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AUH

Identifier Type: OTHER

Identifier Source: secondary_id

AHIL

Identifier Type: -

Identifier Source: org_study_id

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