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Autoimmune Hepatitis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286663
Recruitment Status : Terminated (Principal Investigator moving out of state, no other staff to lead research.)
First Posted : February 3, 2006
Last Update Posted : July 9, 2008
National Institutes of Health (NIH)
Information provided by:
University of Rochester

Brief Summary:

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 or disease
Hepatitis, Autoimmune

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis
Study Start Date : January 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286663

Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
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Principal Investigator: Parvez S Mantry, MD University of Rochester
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Responsible Party: Parvez S. Mantry, MD, University of Rochester Medical Center Liver and Digestive Disease Unit Identifier: NCT00286663    
Other Study ID Numbers: RSRB 12494
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008
Keywords provided by University of Rochester:
AIH, Autoimmune Hepatitis
Additional relevant MeSH terms:
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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