Full Text View
Tabular View
No Study Results Posted
Related Studies
Prediction of Hepatitis C Recurrence in Liver Transplant Recipients
This study is currently recruiting participants.
Verified by Northwestern University, March 2009
First Received: March 19, 2009   Last Updated: March 20, 2009   History of Changes
Sponsors and Collaborators: Northwestern University
Northwestern University Feinberg School of Medicine
Department of Surgery Division of Organ Transplantation
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00867243
  Purpose

The purpose of the study is to look at cells of the immne system to see if the cells are different among people with different risk factors that have received a liver translant. 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.


Condition
Liver Transplant
Hepatitis C Virus

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence

Secondary Outcome Measures:
  • To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients
  • 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.

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: October 2009
Groups/Cohorts
1
50 patients whom are HCV positive
2
50 patients whom are HCV negative.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867243

Contacts
Contact: Talia Baker, MD 312-695-0401 tabaker@nmh.org
Contact: Anat Tambur, MD, PhD 312-503-2949 a-tambur@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Talia Baker, MD            
Principal Investigator: Anat Tambur, MD, PhD            
Sponsors and Collaborators
Northwestern University
Northwestern University Feinberg School of Medicine
Department of Surgery Division of Organ Transplantation
Investigators
Principal Investigator: Talia Baker, MD Northwestern Memorial Hospital
Principal Investigator: Anat Tambur, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern Memorial Hospital ( Talia Baker, ME )
Study ID Numbers: 1963-002
Study First Received: March 19, 2009
Last Updated: March 20, 2009
ClinicalTrials.gov Identifier: NCT00867243     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
HCV

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C
Recurrence

Additional relevant MeSH terms:
Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on May 07, 2009