Clinical Trial: Protective Immune Mechanisms in Alcoholic Hepatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Protective Immune Mechanisms in Alcoholic Hepatitis

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 Summary: 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.
Sponsor: University of Aarhus

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • 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.
  • 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.
  • Signalling molecules and markers of hepatocyte destruction [ Time Frame: at day 1, at day 7 and at day 30 after diagnosis. ]
    Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 30.


Information By: University of Aarhus

Dates:
Date Received: June 25, 2013
Date Started: April 2013
Date Completion: January 2018
Last Updated: February 24, 2016
Last Verified: February 2016