Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in China / NCT06147375
Starting soon Not applicable

Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

NCT06147375 · tracked via the Priya Life Science China tracker
Sponsor
Wei Gao
Phase
Not applicable
Started
2023-12-01
Last updated
2023-11-27

Condition(s) studied

Immune ToleranceImmunosuppressionLiver Transplant; Complications

Investigational drug(s) / intervention(s)

Tacrolimus or Cyclosporine AAll Tacrolimus trials (47) →All Cyclosporine A trials (5) →

Tacrolimus or Cyclosporine A: The protocol of IS withdrawal:Week 1-4 take Tacrolimus (Tac) or Cyclosporine A (CsA) once daily for weeks. Week 5-8 medication reduction to taking Tac / CsA 4 times a week . Week 9-12 reduction to taking Tac/ CsA 3 times a week. Week 13-18 reduction to taking Tac / CsA 2 times a week . Week 19-24 reduction to taking Tac/ CsA once per week. Week 25, the recipients will stop taking Tac/ CsA.

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of immune tolerance participants — Enrollment to 2 year post cessation of immunosuppression
    Number of participants who are immune tolerance, defined as those who successfully withdraw from immunosuppression and maintain normal graft status as assessed by liver biopsy and liver tests 2 years after complete immunosuppression withdrawal.

Trial sites (1)

FacilityCityRegionStatus
Tianjin First Central Hospital Tianjin Tianjin Municipality

Other trials for the same condition

Thymalfasin for Immune Recovery in Adults With Sepsis Recruiting
Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Starting soon
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients Recruiting
Design and Implementation of the Pediatric Liver Transplantation Biobank Recruiting
Combined Immunosuppression for Pediatric Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06147375 on ClinicalTrials.gov ↗ ← All trials in China