Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C, Chronic; Complication of Transplanted Liver

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence	Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients	Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
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.	Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Memorial Hospital
• Investigators: Principal Investigator: Talia Baker, MD, Northwestern Memorial Hospital; Principal Investigator: Anat Tambur, MD, PhD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C virus; Hepatitis C (and cirrhosis); Liver cirrhosis not due to HCV infection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Recurrence; Hepatitis C, Chronic
• Other Study ID Numbers: STU12442 1963-002