AHIL: Protective Immune Mechanisms in Alcoholic Hepatitis

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01918462

Collaborator

(none)

Enrollment

Location

60.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Protective Immune Mechanisms in Alcoholic Hepatitis

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 20, 2018

Actual Study Completion Date :

Apr 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Alcoholic hepatitis Patients with alcoholic hepatic; cases.
Healthy controls Persons undergoing hepatic resection; controls.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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