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Sponsors and Collaborators: |
Northwestern University Northwestern University Feinberg School of Medicine Department of Surgery Division of Organ Transplantation |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00867243 |
The purpose of the study is to look at cells of the immne system to see if the cells are different among people with different risk factors that have received a liver translant. We will enroll 50 patients receiving liver transplant and their donors. Both donor and recipient must participate in the order for the recipient to participate in the study. We will take blood samples from these patients and their donors.
Condition |
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Liver Transplant Hepatitis C Virus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prediction of Hepatitis C Recurrence in Liver Transplant Recipients |
Estimated Enrollment: | 100 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2009 |
Groups/Cohorts |
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1
50 patients whom are HCV positive
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2
50 patients whom are HCV negative.
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To establish whether in-vitro donor-specific immune reactivity patterns can differentiate between those liver transplant recipients who are positive for the Hepatitis C virus (HCV) who are at high risk and those who are at low risk for graft loss secondary to early recurrence of HCV.
An assessment of the recipient's donor-specific immune status can be achieved by measuring T-cell activity, specifically alloreactive primed (donor-specific) T cell activity. It has been shown that detection of IFN-y in short-term enzyme-linked-immunosorbent-spot (ELISPOT) assay is consistent with the presence of primed memory T cells (6). In the transplantation setting, T cells of an allograft recipient that secret IFN-y after short in-vitro exposure to donor cells represent a prior sensitization of recipient to donor antigens in vivo. Clinically interpreted - this priming event may signify the presence of an up-coming, or an on-going, rejection episode. Our limited preliminary data suggest an additional potential clinical value for the in-vitro assessment of donor-specific IFN-y production in predicting those liver transplant recipients at higher risk for recurrence of Hepatitis C.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The target population is males/females over the age of 18 that require liver transplantation, and their donors
Inclusion Criteria:
Exclusion Criteria:
Contact: Talia Baker, MD | 312-695-0401 | tabaker@nmh.org |
Contact: Anat Tambur, MD, PhD | 312-503-2949 | a-tambur@northwestern.edu |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Talia Baker, MD | |
Principal Investigator: Anat Tambur, MD, PhD |
Principal Investigator: | Talia Baker, MD | Northwestern Memorial Hospital |
Principal Investigator: | Anat Tambur, MD, PhD | Northwestern University |
Responsible Party: | Northwestern Memorial Hospital ( Talia Baker, ME ) |
Study ID Numbers: | 1963-002 |
Study First Received: | March 19, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00867243 History of Changes |
Health Authority: | United States: Institutional Review Board |
HCV |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Hepatitis C Recurrence |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C |