Hepatitis, AutoimmuneNCT00286663
Autoimmune Hepatitis Study
An observational study of Hepatitis, Autoimmune, run by University of Rochester.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Autoimmune
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis
Who cannot join
- Subjects with a hematocrit of <25
About this study
Official title: Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis
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
Read the 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
- Keywords
- AIH, Autoimmune Hepatitis
- Medical subject headings
- Hepatitis, Autoimmune
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2006
- Study completionJun 2008
Why it stopped: Principal Investigator moving out of state, no other staff to lead research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AutoimmuneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Parvez S Mantry, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286663
- Sponsor's protocol ID
- RSRB 12494
- Status last verified
- Jul 2008
- First submitted
- 1 Feb 2006
- Last updated
- 9 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cellular Immune Response in Patients With Anti-SLA/LP- or Anti-LKM-Positive Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT00286663
- Acronym / sponsor ID
- RSRB 12494
- Conditions
- Hepatitis, Autoimmune
- Keywords
- AIH, Autoimmune Hepatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator moving out of state, no other staff to lead research.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2006
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects,All ethnic groups, Over 18 years of age, anti-SLA/LP or anti-LKM-positive autoimmune hepatitis
Key exclusion criteria (1 listed)
- Subjects with a hematocrit of <25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Principal Investigator moving out of state, no other staff to lead research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parvez S Mantry, MD principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, Autoimmune, run by University of Rochester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator moving out of state, no other staff to lead research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2008.