Study of T Cell Phenotype Activation Pathway in Human Alc... | NCT00610597

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

NCT00610597

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Feb 8, 2008Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Alcoholic Liver Disease
Chronic Hepatitis C Virus

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

ID	Type	Description	Link
AL-ALD

Status Module

Record Verification Date

Jan 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

Jan 2008Actual

First Submitted Date

Jan 28, 2008

First Submission Date that Met QC Criteria

Jan 28, 2008

First Posted Date

Feb 8, 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

Jan 28, 2008

Last Update Posted Date

Feb 8, 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

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.

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.

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

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		alcoholic liver disease
2		chronic hepatitis C virus infection

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:

bacterial or fungal infection
immunosuppressive treatment
other causes of 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			Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19177575	Derived	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.

ID	Term
D008108	Liver Diseases, Alcoholic
D019698	Hepatitis C, Chronic

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