Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

Hepatitis C, Chronic Clinical Trial

Official title:

Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00867243
• Other study ID #: STU12442 1963-002
• Status: Terminated
• Phase: N/A
• First received: March 19, 2009
• Last updated: June 10, 2013
• Start date: October 2005
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication of Transplanted Liver
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No