Clinical trial NCT00867243: Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
Official title: Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complication of Transplanted Liver
Hepatitis C, Chronic
Keywords: Hepatitis C virus
HCV
Hepatitis C (and cirrhosis)
Liver cirrhosis not due to HCV infection
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
First posted: 2009-03-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is males/females over the age of 18 that require liver transplantation, and their donors

Brief summary: 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.

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 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

Primary outcomes:
measure: To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence
timeFrame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
Secondary outcomes:
measure: To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients
timeFrame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
measure: 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.
timeFrame: Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern Memorial Hospital
name: Talia Baker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Anat Tambur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tambur AR, Ben-Ari Z, Herrera ND, Klein T, Michowiz R, Mor E. Donor-specific hyporesponsiveness in ELISPOT assay is associated with early recurrence of hepatitis C in liver transplant recipients. Hum Immunol. 2005 Jan;66(1):21-7. doi: 10.1016/j.humimm.2004.08.180.