Immune Tolerance After Pediatric Liver Transplantation

Launched by RENJI HOSPITAL · Aug 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the possibility of "immune tolerance" in children who have received a liver transplant. Immune tolerance means that some patients can stop taking immunosuppressive (IS) medications, which help prevent the body from rejecting the new liver, while still maintaining normal liver function. The researchers want to find out how many pediatric liver transplant recipients can achieve this and how safe it is over the long term. They will follow children aged 4 months to 18 years who had a successful liver transplant from a living donor, such as a parent, and have stable liver function for at least three months before joining the study.

If your child is eligible, they will be monitored closely during the trial. This includes regular check-ups on liver function and health, especially if they are taking fewer or no immunosuppressive medications. The study will help determine the rate of immune tolerance, any episodes of liver rejection, and possible complications that may arise during this process. It's important to know that participation in this trial requires written consent and careful monitoring to ensure your child’s safety and well-being throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age at liver transplantation: 4 months to 18 years;
• • 2. Original disease before liver transplantation: End-stage liver diseases including cholestatic diseases or metabolic diseases;
• • 3. Type of liver transplantation: living donor liver transplantation, with donors of recipient's parents
• • 4. Follow-up time after liver transplantation: more than one year
• • 5. Liver function: liver function maintains normal and stable 3 months before enrollment
• • 6. IS strategy: monotherapy of IS (FK or cyclosporine) or no longer taking any IS
• • 7. Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\<2)
• • 8. Written consents are required
• Exclusion Criteria:
• • 1. Original disease before liver transplantation: Tumor, hepatitis virus infection, autoimmune hepatitis, liver failure, secondary liver transplantation
• • 2. Type of liver transplantation: ABO incompatible liver transplantation, donors are not recipient's parents or multiple organ transplantation
• • 3. Hepatitis virus infection during follow-up
• • 4. Severe compilations, including bleeding complication, biliary complication, vessel complication or renal dysfunction -