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NCT00286663 Clinical Trial

Autoimmune Hepatitis Study

Hepatitis, Autoimmune Clinical Trial

Official title:
Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00286663
Other study ID # RSRB 12494
Secondary ID
Status Terminated
Phase Phase 1
First received February 1, 2006
Last updated July 8, 2008
Start date January 2006
Est. completion date June 2008

Study information
Verified date July 2008
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Rochester National Institutes of Health (NIH)
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