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

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00610597
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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
Alcoholic Liver Disease
Chronic Hepatitis C Virus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Biospecimen Retention:   Samples Without DNA

plasma and peripheral blood mononuclear cell culture medium.


Enrollment: 49
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
alcoholic liver disease
2
chronic hepatitis C virus infection

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients of Erasme University Hospital

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610597

Locations
Belgium
Hopital Erasme - Dpt of Gastroenterology
Brussels, Belgium
Sponsors and Collaborators
Erasme University Hospital
Investigators
Principal Investigator: Arnaud Lemmers, MD Erasme Hospital, Gastroenterology Dpt
  More Information

No publications provided by Erasme University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00610597     History of Changes
Other Study ID Numbers: AL-ALD, AL-ALD
Study First Received: January 28, 2008
Last Updated: January 28, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by Erasme University Hospital:
liver
alcohol
lymphocyte

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Liver Diseases, Alcoholic
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 24, 2014