NCT00770198

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 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
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
Last Updated

October 9, 2008

Status Verified

October 1, 2008

Enrollment Period

2 years

First QC Date

October 8, 2008

Last Update Submit

October 8, 2008

Conditions

Alcoholic Liver DiseaseChronic Hepatitis C Virus Infection

Keywords

liveralcoholHCV

Study Arms (2)

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

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:

  • other (superimposed) liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme - Dpt of Gastroenterology

Brussels, 1070, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, liver biopsies, and peripheral blood mononuclear cell culture medium.

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

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

October 8, 2008

First Posted

October 9, 2008

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

October 1, 2008

Last Updated

October 9, 2008

Record last verified: 2008-10

Locations

BE(1)