Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

Launched by WEI GAO · Nov 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the possibility of safely stopping immunosuppressive medications in children who have received a liver transplant. These medications are usually given to prevent the body from rejecting the new liver. The main goal of the study is to understand how some children may develop a tolerance to their new liver, meaning their body accepts it without needing ongoing medication. Researchers will enroll 47 children under the age of 6 who have had their liver transplant for over four years and are currently healthy. They will analyze blood and liver tissue samples to find markers that can help predict who can safely stop taking these medications.

To participate, children must have normal liver function and no signs of liver rejection in their biopsies for at least two years. They cannot have had certain serious illnesses or complications related to their liver disease. Parents and guardians will need to provide written consent for their child to join the study. Throughout the trial, participants will be monitored closely as their medications are gradually reduced, and researchers will use advanced techniques to identify those who can maintain their health without immunosuppressive drugs. This trial is important as it may help improve the long-term care of pediatric liver transplant recipients by potentially reducing the need for lifelong medications.

Gender

ALL

Eligibility criteria

• 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