Autoimmune Hepatitis Study | NCT00286663

Studies
Autoimmune Hepatitis Study

NCT00286663

Sponsor

University of Rochester

Status

Terminated

Last Update Posted

Jul 9, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatitis, Autoimmune

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jun 2008Actual

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2008

Last Update Posted Date

Jul 9, 2008Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Parvez S Mantry, MD	University of Rochester	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D019693	Hepatitis, Autoimmune

Ancestor Terms

ID	Term
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided