Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00867243

Enrollment

Registered

2009-03-23

Start date

2005-10-31

Completion date

2011-05-31

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Transplanted Liver, Hepatitis C, Chronic

Keywords

Hepatitis C virus, HCV, Hepatitis C (and cirrhosis), Liver cirrhosis not due to HCV infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results