Autoimmune Hepatitis Study

This study has been terminated.

( Principal Investigator moving out of state, no other staff to lead research. )

First Received: February 1, 2006 Last Updated: July 8, 2008 History of Changes

Sponsors and Collaborators:	University of Rochester National Institutes of Health (NIH)
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00286663

Purpose

The purpose of the study is to determine the role special antibodies play in possibly identifying Autoimmune Hepatitis through the following:

Identify the response of specific T cells to antibodies and Monitor the response of the cells that regulate the immune system

Condition	Phase
Hepatitis, Autoimmune	Phase I

MedlinePlus related topics: Hepatitis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis

Further study details as provided by University of Rochester:

Estimated Enrollment:	100
Study Start Date:	January 2006
Study Completion Date:	June 2008

Detailed Description:

The object of this protocol is to characterize and monitor auto antigen-specific T cell responses in blood and liver biopsies of patients with anti-SLA/LP or anti-LKM-positive autoimmune hepatitis. The results will provide insight into the pathogenesis of autoimmune hepatitis and the monitoring of auto antigen-specific T cell reactivity in correlation to disease exacerbation and therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis

Exclusion Criteria:

Subjects with a hematocrit of <25

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286663

Sponsors and Collaborators

University of Rochester

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Parvez S Mantry, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester Medical Center Liver and Digestive Disease Unit ( Parvez S. Mantry, MD )
Study ID Numbers:	RSRB 12494
Study First Received:	February 1, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00286663 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

AIH, Autoimmune Hepatitis

Study placed in the following topic categories:

Hepatitis
Liver Diseases
Autoimmune Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Autoimmune
Autoimmune Hepatitis

Additional relevant MeSH terms:

Hepatitis
Liver Diseases
Autoimmune Diseases
Digestive System Diseases

Immune System Diseases
Hepatitis, Chronic
Hepatitis, Autoimmune

ClinicalTrials.gov processed this record on May 07, 2009