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Completed

NCT Number: NCT01918462

Protective Immune Mechanisms in Alcoholic Hepatitis

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.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hepatology and gastroenterology V, Aarhus university hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of IL-22-producing cells

    Time frame: 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 outcomes

  1. IL-22 binding protein

    Time frame: at day 1 ( the day of diagnosis/arrival to the department)

    This will be detected in hepatic biopsies taken at inclusion to the study.

  2. IL-22 receptor

    Time frame: at day 1 ( the day of diagnosis/arrival to the department)

    This will be detected in hepatic biopsies taken at inclusion to the study.

  3. Signalling molecules and markers of hepatocyte destruction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: AHIL

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2013
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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