Status:
NOT_YET_RECRUITING
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
Lead Sponsor:
Wei Gao
Conditions:
Immune Tolerance
Immunosuppression
Eligibility:
All Genders
4+ years
Phase:
NA
Brief 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...
Detailed Description
Background: The main conditions which require pediatric liver transplantation are benign diseases with curable primary diseases, such as metabolic and biliary diseases. After liver transplantation, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06147375
Start Date
December 1 2023
End Date
December 1 2028
Last Update
November 27 2023
Active Locations (1)
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1
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300192