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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
Northwestern Memorial Hospital |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00867243 |
Purpose
The purpose of the study is to look at cells of the immune system to see if the cells are different among people with different risk factors that have received a liver transplant. 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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Complication of Transplanted Liver Hepatitis C, Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prediction of Hepatitis C Recurrence in Liver Transplant Recipients |
Recipient specimens: Peripheral blood draws at baseline and follow-up clinic visits.
Donor specimens: Donor cells will be isolated from lymph nodes obtained at time of harvest; if living donor - blood taken at time of liver resection surgery.
| Enrollment: | 24 |
| Study Start Date: | October 2005 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Group 1: HCV Positive
50 patients whom are HCV positive
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Group 2: HCV Negative
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.
Eligibility| 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:
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Talia Baker, MD | Northwestern Memorial Hospital |
| Principal Investigator: | Anat Tambur, MD, PhD | Northwestern University |
More Information
| Responsible Party: | Talia Baker, ME, Northwestern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00867243 History of Changes |
| Other Study ID Numbers: | STU12442 1963-002 |
| Study First Received: | March 19, 2009 |
| Last Updated: | August 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Hepatitis C virus HCV Hepatitis C (and cirrhosis) Liver cirrhosis not due to HCV infection |
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Hepatitis Hepatitis A Hepatitis C Recurrence Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Disease Attributes Pathologic Processes Hepatitis, Chronic |