Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992888

Acronym

Heliac

Enrollment

Registered

2009-10-09

Start date

2009-08-31

Completion date

2011-09-30

Last updated

2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic Hepatitis, Alcohol, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors

Brief summary

The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.

Interventions

DEVICEPrometheus Liver Dialysis system (Fresenius Medical Care)

6 hour dialysis for 3 consecutive days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

Patients with alcoholic hepatitis based on the following criteria * Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier. * Serum bilirubin level above 80 mmol/l * exclusion of other types of liver disease. * Liver biopsy when diagnosis is unclear.

Exclusion criteria

* Heart failure * Pregnancy * non fluent danish speakers

Design outcomes

Primary

Measure	Time frame
Serum endotoxin levels	one year

Secondary

Measure	Time frame
Endotoxin activation pathway proteins	1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026