Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

NCT ID: NCT00867243

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2011-05-31

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.

Conditions

Complication of Transplanted Liver; Hepatitis C, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: HCV Positive

50 patients whom are HCV positive

No interventions assigned to this group

Group 2: HCV Negative

50 patients whom are HCV negative.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Memorial Hospital

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

TBaker

Assitant Professor of Surgery, Division of Organ Transplantation, Dept of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talia Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital

Anat Tambur, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15620458 (View on PubMed)

Other Identifiers

STU12442 1963-002

Identifier Type: -

Identifier Source: org_study_id