sgp130 in Chronic Human Liver Disease | NCT00770198

Studies
sgp130 in Chronic Human Liver Disease

NCT00770198

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Oct 9, 2008Estimated

Enrollment

129Actual

Phase

Not provided

Conditions

Alcoholic Liver Disease
Chronic Hepatitis C Virus Infection

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Oct 2008Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 8, 2008

First Posted Date

Oct 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2008

Last Update Posted Date

Oct 9, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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:

other (superimposed) liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients of Erasme University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud Lemmers, MD	Erasme Hospital, Gastroenterology Dpt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Erasme - Dpt of Gastroenterology		Brussels		1070	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D008108	Liver Diseases, Alcoholic

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D020751	Alcohol-Induced Disorders
D019973	Alcohol-Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided