Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liv… (NCT02533180) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
United States100 participantsStarted 2015-12-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At the time of screening:
. Recipient of either deceased or living donor liver transplant. Recipients of living donor transplants must have a donor who is also willing to enroll
. Recipient of single organ transplant only
. Must have a screening liver biopsy that fulfills the following criteria based on the central pathology reading:
. Liver function tests (Direct bilirubin, alanine aminotransferase (ALT)), less than twice the upper limit of normal (ULN). ULN values for liver function tests will be defined by ranges from Harrison's Principles of Internal Medicine, 18th edition
. Receiving calcineurin inhibitor (CNI) based maintenance immunosuppression. Participants may also concurrently receive:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Percent of Participants Who Achieve Operational Tolerance 52 Weeks After Completion of Immunosuppression Withdrawal.
Timeframe: From initiation of immunosuppression withdrawal through 52 weeks after stopping all immunosuppression
Trial details
NCT IDNCT02533180
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. History of hepatitis C virus (HCV) infection (defined as a positive HCV antibody test)
. Positive antigen-antibody immunoassay for human immunodeficiency virus, HIV-1/2
. Serum positivity for HBV surface antigen or HBV-DNA
. History of immune-mediated liver disease in which immunosuppression discontinuation is inadvisable (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis)
. Any medical condition associated with a likely need for systemic corticosteroid administration, e.g., reactive airways disease
. Prospective baseline liver biopsy showing any of the following: (see recipient inclusion criteria #4)
. Rejection within the 52 weeks prior to screening
. Estimated glomerular filtration rate (GFR) \<40 ml/min as calculated by CKD-EPI method (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI be required)