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Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis (Heliac)

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ClinicalTrials.gov Identifier: NCT00992888
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):
Thomas Damgaard Sandahl, University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Device: Prometheus Liver Dialysis system (Fresenius Medical Care) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
Study Start Date : August 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: albumin liver dialysis Device: Prometheus Liver Dialysis system (Fresenius Medical Care)
6 hour dialysis for 3 consecutive days
Other Name: The prometheus albumin dialysis by Fresenius Medical Care
No Intervention: Standard medial care without dialysis



Primary Outcome Measures :
  1. Serum endotoxin levels [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Endotoxin activation pathway proteins [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992888


Locations
Denmark
Department of Medicine V, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Hendrik Vilstrup, Prof Department of Medicine V, Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Damgaard Sandahl, Dr, University of Aarhus
ClinicalTrials.gov Identifier: NCT00992888     History of Changes
Other Study ID Numbers: Heliac-01
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

Keywords provided by Thomas Damgaard Sandahl, University of Aarhus:
Alcoholic Hepatitis
Alcohol
Endotoxin
LPS
Liver dialysis
Innate immunity
Toll Like receptors

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hypertension
Hepatitis
Hepatitis A
Inflammation
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders