Protective Immune Mechanisms in Alcoholic Hepatitis

NCT01918462 | Completed DMC

• 2 other identifiers: AHILAUH
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic hepatitis; IL-22; Kupffer cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• IL-22 binding protein

  at day 1 ( the day of diagnosis/arrival to the department)

• IL-22 receptor

  at day 1 ( the day of diagnosis/arrival to the department)

• Signalling molecules and markers of hepatocyte destruction

  at day 1, at day 7 and at day 90 after diagnosis.

Study Arms (2)

Alcoholic hepatitis

Patients with alcoholic hepatic; cases.

Healthy controls

Persons undergoing hepatic resection; controls.

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• histological verification on liver biopsy
• Written, informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Hepatology and gastroenterology V, Aarhus university hospital

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Sidsel Støy, Phd student

  Department of hepatology and gastroenterology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: August 7, 2013
• Study Start: April 1, 2013
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: April 29, 2021

Record last verified: 2018-10

Locations

DK (1)