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Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
This study has been terminated.
( This project is no longer being adequately supported to allow completion )

First Received on March 19, 2009.   Last Updated on August 17, 2011   History of Changes
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
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence [ Time Frame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients [ Time Frame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18 ] [ Designated as safety issue: No ]
  • To establish immune monitoring protocol for HCV+ liver transplant recipients that will aid in tailoring immunosuppression protocols for these patients and in devising strategies to treat patients with recurrent hepatitis C post-liver transplantation. [ Time Frame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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
Group 1: HCV Positive
50 patients whom are HCV positive
Group 2: HCV Negative
50 patients whom are HCV negative.

Detailed Description:

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
Study Population

The target population is males/females over the age of 18 that require liver transplantation, and their donors

Criteria

Inclusion Criteria:

  • Patients must be >18 years of age
  • Chronic HCV infection (and cirrhosis) - group 1
  • HCV RNA positive pre-transplant - group 1
  • Liver cirrhosis not due to HCV infection - group 2

Exclusion Criteria:

  • All patients < than 18 years of age
  • Patients with hepatitis C infection
  • Candidates receiving multi-organ combined transplantation
  • Patients who have received a previous liver transplantation
  • Patients who are unable to understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867243

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
Investigators
Principal Investigator: Talia Baker, MD Northwestern Memorial Hospital
Principal Investigator: Anat Tambur, MD, PhD Northwestern University
  More Information

Publications:
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

Keywords provided by Northwestern University:
Hepatitis C virus
HCV
Hepatitis C (and cirrhosis)
Liver cirrhosis not due to HCV infection

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 12, 2012