Autoimmune Hepatitis Study

NCT ID: NCT00286663

Last Updated: 2008-07-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-06-30

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

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.

Conditions

Hepatitis, Autoimmune

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

University of Rochester Medical Center Liver and Digestive Disease Unit

Principal Investigators

Parvez S Mantry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Other Identifiers

RSRB 12494

Identifier Type: -

Identifier Source: org_study_id