NCT00867243|Terminated
Study Stopped
This project is no longer being adequately supported to allow completion
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This project is no longer being adequately supported to allow completion
Sponsor study identifier
observational
24
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 19, 2009
Actual (reported)March 23, 2009
Actual (reported)May 2010
Actual (reported)May 2011
Actual (reported)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
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
50 patients whom are HCV positive
50 patients whom are HCV negative.
The target population is males/females over the age of 18 that require liver transplantation, and their donors
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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.
Recipient specimens: Peripheral blood draws at baseline and follow-up clinic visits. Donor specimens: Donor cells will be isolated from lymph nodes obtained at time of harvest; if living donor - blood taken at time of liver resection surgery.
Talia Baker, MD
Northwestern Memorial Hospital
Anat Tambur, MD, PhD
Northwestern University
24 participants (actual enrollment reported by the registry).
First Submitted
March 19, 2009
First Posted
March 23, 2009
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
June 11, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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