Protective Immune Mechanisms in Alcoholic Hepatitis (AHIL)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014