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Protective Immune Mechanisms in Alcoholic Hepatitis (AHIL)

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ClinicalTrials.gov Identifier: NCT01918462
Recruitment Status : Recruiting
First Posted : August 7, 2013
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date June 25, 2013
First Posted Date August 7, 2013
Last Update Posted Date February 19, 2018
Study Start Date April 2013
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2013)
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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 24, 2016)
  • 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 Measures
 (submitted: August 5, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protective Immune Mechanisms in Alcoholic Hepatitis
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, plasma, PBMC's, hepatic leukocytes
Sampling Method Probability Sample
Study Population Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital
Condition Alcoholic Hepatitis
Intervention Not Provided
Study Groups/Cohorts
  • Alcoholic hepatitis
    Patients with alcoholic hepatic; cases.
  • Healthy controls
    Persons undergoing hepatic resection; controls.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 15, 2018)
55
Original Estimated Enrollment
 (submitted: August 5, 2013)
60
Estimated Study Completion Date January 2022
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sidsel Støy 004578463897 sidsel.stoy@clin.au.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01918462
Other Study ID Numbers AHIL
AUH ( Other Identifier: Aarhus University hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Sidsel Støy, Phd student Department of hepatology and gastroenterology, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date February 2018