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sgp130 in Chronic Human Liver Disease

Sponsor
Erasme University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00770198
Collaborator
(none)
129
Enrollment
1
Location
45
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic liver disease are characterized by increased levels of plasma IL-6, but the bioactivity of this cytokine in this disease is not well known. IL-6 receptor complex is regulated by multiple receptors subunits: the soluble form of IL-6 Receptor enhance IL-6 signal by a process called trans-signaling on cells expressing few membrane IL-6 receptors. Soluble gp130 is the natural inhibitor of IL-6 trans-signaling. The aim of this study is to characterize circulating and liver levels of theses compounds of IL-6 receptor complex, to unravel the bioactivity of IL-6 in this disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver IL-6R compounds mRNA levels.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    129 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Study of IL-6 Transsignaling in Chronic Human Liver Disease
    Study Start Date :
    Jan 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2007
    Actual Study Completion Date :
    Oct 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    alcoholic liver disease

    alcoholic liver disease patients undergoing a transjugular liver biospy in our institution
    chronic HCV hepatitis

    chronic HCV hepatitis patients undergoing a transjugular liver biopsy in our institution

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Alcohol excess intake and suspected liver disease

      • Alcohol excess intake and clinical liver cirrhosis

      • chronic hepatitis C virus infection and suspected liver disease

      • chronic hepatitis C virus infection and clinical liver cirrhosis

      Exclusion Criteria:
      • other (superimposed) liver disease

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hopital Erasme - Dpt of Gastroenterology Brussels Belgium 1070

      Sponsors and Collaborators

      • Erasme University Hospital

      Investigators

      • Principal Investigator: Arnaud Lemmers, MD, Erasme Hospital, Gastroenterology Dpt

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00770198
      Other Study ID Numbers:
      • AL-gp130
      First Posted:
      Oct 9, 2008
      Last Update Posted:
      Oct 9, 2008
      Last Verified:
      Oct 1, 2008
      Keywords provided by , ,
      liver
      alcohol
      HCV
      Additional relevant MeSH terms:
      Hepatitis C
      Hepatitis C, Chronic
      Liver Diseases
      Liver Diseases, Alcoholic

      Study Results

      No Results Posted as of Oct 9, 2008