Protective Immune Mechanisms in Alcoholic Hepatitis (AHIL)

This study is currently recruiting participants.
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01918462
First received: June 25, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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
Alcoholic Hepatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protective Immune Mechanisms in Alcoholic Hepatitis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Frequency of IL-22-producing cells [ Time Frame: at day 1 ( the day of diagnosis/arrival to the department) ] [ Designated as safety issue: No ]
    This will be detected in hepatic biopsies taken at inclusion to the study.


Secondary Outcome Measures:
  • IL-22 binding protein [ Time Frame: at day 1 ( the day of diagnosis/arrival to the department) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 30.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, PBMC's, hepatic leukocytes


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alcoholic hepatitis
Patients with alcoholic hepatic; cases.
Healthy controls
Persons undergoing hepatic resection; controls.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918462

Contacts
Contact: Sidsel Støy 004578463897 sidsel.stoy@ki.au.dk

Locations
Denmark
Department of Hepatology and gastroenterology V, Aarhus university hospital Recruiting
Aarhus, Denmark, 8000
Contact: Sidsel Støy, Phd Student    004578464087    sidsel.stoy@ki.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Sidsel Støy, Phd student Department of hepatology and gastroenterology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01918462     History of Changes
Other Study ID Numbers: AHIL, AUH
Study First Received: June 25, 2013
Last Updated: August 5, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Alcoholic hepatitis
IL-22
Kupffer cells

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 16, 2014