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Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
This study is currently recruiting participants.
Study NCT00867243   Information provided by Northwestern University
First Received: March 19, 2009   Last Updated: March 20, 2009   History of Changes

March 19, 2009
March 20, 2009
October 2005
 
To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence
Same as current
Complete list of historical versions of study NCT00867243 on ClinicalTrials.gov Archive Site
  • To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients
  • 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.
Same as current
 
Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

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.

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.

 
Observational
Cohort, Prospective
  • Liver Transplant
  • Hepatitis C Virus
 
  • 50 patients whom are HCV positive
  • 50 patients whom are HCV negative.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
October 2009
 

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
Both
18 Years and older
No
Contact: Talia Baker, MD 312-695-0401 tabaker@nmh.org
Contact: Anat Tambur, MD, PhD 312-503-2949 a-tambur@northwestern.edu
United States
 
NCT00867243
Talia Baker, ME, Northwestern Memorial Hospital
1963-002
Northwestern University
  • Northwestern University Feinberg School of Medicine
  • Department of Surgery Division of Organ Transplantation
Principal Investigator: Talia Baker, MD Northwestern Memorial Hospital
Principal Investigator: Anat Tambur, MD, PhD Northwestern University
Northwestern University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP