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Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Sponsor
Erasme University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00610597
Collaborator
(none)
49
Enrollment
1
Location
36
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver 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 T cell infiltrates.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    49 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
    Study Start Date :
    Jan 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2007
    Actual Study Completion Date :
    Jan 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    1

    alcoholic liver disease
    2

    chronic hepatitis C virus infection

    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:

      • bacterial or fungal infection

      • immunosuppressive treatment

      • other causes of liver disease

      Contacts and Locations

      Locations

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

      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:
      NCT00610597
      Other Study ID Numbers:
      • AL-ALD
      • AL-ALD
      First Posted:
      Feb 8, 2008
      Last Update Posted:
      Feb 8, 2008
      Last Verified:
      Jan 1, 2008
      Keywords provided by , ,
      liver
      alcohol
      lymphocyte
      Additional relevant MeSH terms:
      Hepatitis C
      Hepatitis C, Chronic
      Liver Diseases
      Liver Diseases, Alcoholic

      Study Results

      No Results Posted as of Feb 8, 2008