Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation (NCT06147375) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
China47 participantsStarted 2023-12-01
Plain-language summary
The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients. The main question it aims to answer is:exploring the landscape of immune tolerance after pediatric liver transplantation. Moreover,this clinical trial aims to provide important foundation and clinical data for inducing immune tolerance, as well as to clarify the mechanism of immune tolerance development in pediatric liver transplantation, identify biomarkers that can be used to predict immune tolerance, and build a prediction model of immune tolerance after pediatric liver transplantation.
The study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal immunosuppressive after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of immunosuppressive withdrawal.In this study, we collect the peripheral blood and liver biopsy samples from the two groups, find biomarkers with predictive value for immune tolerance in recipients after pediatric liver transplantation, and build a predictive model of immune tolerance by machine learning.
Who can participate
Age range
4 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:
* Age at liver transplantation: under 6 years
* Follow-up time after liver transplantation: more than 4 years
* Liver function maintains normal before enrollment
* Monotherapy of IS (Tacrolimus or Cyclosporine A)
* Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\<2) 2 years before enrollment
* Female recipients of fertility treatment must have a negative pregnancy test before enrollment
* No Hepatitis virus infection 1 year before enrollment
* Written consents are required
Exclusion Criteria:
* Original disease before liver transplantation: Tumor, secondary liver transplantation, hepatitis virus infection, autoimmune hepatitis
* Type of liver transplantation: ABO incompatible liver transplantation or multiple organ transplantation
* Liver biopsy: obvious fibrosis(Ishak≥2；LAFSc moderate or severe)
* Recipients taking IS for other diseases besides their liver transplantation
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
Number of immune tolerance participants
Timeframe: Enrollment to 2 year post cessation of immunosuppression