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Autoimmune Hepatitis Study

This study has been terminated.
(Principal Investigator moving out of state, no other staff to lead research.)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00286663
First received: February 1, 2006
Last updated: July 8, 2008
Last verified: July 2008
History of Changes
  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 1

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

Resource links provided by NLM:

U.S. FDA Resources

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

Keywords provided by University of Rochester:
AIH, Autoimmune Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013