a study on Liver Transplant
The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults (ITN056ST)
People who have liver transplants must take anti-rejection medication (immunosuppression) for the rest of their lives. If they stop, their immune system may reject the transplanted liver. All anti-rejection medications have side effects. Because of the side effects of anti-rejection medications, an important goal of transplant research is to allow people to accept their transplanted organ without long term use of anti-rejection medications. This is called tolerance. In this study, participants who received a liver transplant will have their anti-rejection medication(s) gradually reduced over a period of time and then stopped. The study calls this 'immunosuppression withdrawal'.
The purpose of this research study is to see how many people will develop tolerance after immunosuppression withdrawal. The researchers also want to find out if there are blood or liver biopsy tests that can help transplant doctors in the future predict whether it is safe to decrease or stop anti-rejection medications in people who received a liver transplant.
Liver Transplant Liver Transplantation Liver allograft recipient Immunosuppression withdrawal Calcineurin inhibitor (CNI) based immunosuppression Living Donor (of the Respective Liver Transplant Recipient) Liver Extracts Calcineurin Inhibitors
Open to people ages 18 years and up
Recipient participants must meet all of the following criteria to be eligible for this study:
At the time of screening:
Must have a screening liver biopsy that fulfills the following criteria based on the central pathology reading:
Participants may also concurrently receive:
Prednisone ≤ 7.5 mg daily, or equivalent corticosteroid..
Living donor participants must meet all of the following criteria to be eligible for this study:
Recipient participants who meet any of the following criteria will not be eligible for this study:
Prospective baseline liver biopsy showing any of the following: (see recipient inclusion criteria #4)
Participation in another interventional clinical trial within the 4 weeks prior to screening.
Living donor participants who meet any of the following criteria will not be eligible for this study:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02533180.
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