NCT00610597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

February 8, 2008

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

January 28, 2008

Last Update Submit

January 28, 2008

Conditions

Alcoholic Liver DiseaseChronic Hepatitis C Virus

Keywords

liveralcohollymphocyte

Study Arms (2)

1

alcoholic liver disease

2

chronic hepatitis C virus infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of Erasme University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • bacterial or fungal infection
  • immunosuppressive treatment
  • other causes of liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme - Dpt of Gastroenterology

Brussels, Belgium

Location

Related Publications (1)

  • Lemmers A, Moreno C, Gustot T, Marechal R, Degre D, Demetter P, de Nadai P, Geerts A, Quertinmont E, Vercruysse V, Le Moine O, Deviere J. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009 Feb;49(2):646-57. doi: 10.1002/hep.22680.

    PMID: 19177575DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and peripheral blood mononuclear cell culture medium.

MeSH Terms

Conditions

Liver Diseases, AlcoholicHepatitis C, Chronic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersHepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud Lemmers, MD

    Erasme Hospital, Gastroenterology Dpt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2008

Last Updated

February 8, 2008

Record last verified: 2008-01

Locations

BE(1)