Protective Immune Mechanisms in Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

— AHIL  

Official title:

Protective Immune Mechanisms in Alcoholic Hepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918462
• Other study ID #: AHIL
• Secondary ID: AUH
• Status: Completed
• Start date: April 2013
• Est. completion date: April 20, 2018

Study information

• Verified date: October 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Locations

Country	Name	City	State
Denmark	Department of Hepatology and gastroenterology V, Aarhus university hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of IL-22-producing cells	This will be detected in hepatic biopsies taken at inclusion to the study.	at day 1 ( the day of diagnosis/arrival to the department)
Secondary	IL-22 binding protein	This will be detected in hepatic biopsies taken at inclusion to the study.	at day 1 ( the day of diagnosis/arrival to the department)
Secondary	IL-22 receptor	This will be detected in hepatic biopsies taken at inclusion to the study.	at day 1 ( the day of diagnosis/arrival to the department)
Secondary	Signalling molecules and markers of hepatocyte destruction	Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 90 after diagnosis.	at day 1, at day 7 and at day 90 after diagnosis.