Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

NCT06147375 | Not Yet Recruiting

• 1 other identifier: 2023DZX32
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Immune Tolerance; Immunosuppression; Liver Transplant; Complications

Keywords

Immune Tolerance; Pediatric liver transplant; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Number of immune tolerance participants

  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.

  Enrollment to 2 year post cessation of immunosuppression

Secondary Outcomes (3)

• Number of participants with complications attributed to immunosuppression withdrawal

  Enrollment to 4 year post cessation of immunosuppression

• Impact of iImmunosuppression withdrawal on graft histology

  Enrollment to 4 year post cessation of immunosuppression

• Severity of acute rejection in immunotolerant recipients

  Enrollment to 2 year post cessation of immunosuppression

Study Arms (1)

immunosuppressive withdrawal

EXPERIMENTAL

After enrollment,the recipients will take IS withdrawal follow the protocol of this study.Following enrollment, recipients will be examined at several time periods such as peripheral blood test,liver function , liver biopsy, and other relevant indicators to determine immunosuppressant withdrawal condition and adverse effects.

Drug: Tacrolimus or Cyclosporine A

Interventions

Tacrolimus or Cyclosporine A DRUG

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.

Also known as: immunosuppression withdrawal

immunosuppressive withdrawal

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wei Gao: lead

Study Sites (1)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

MeSH Terms

Interventions

Tacrolimus; Cyclosporine

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Wei Gao, MD

  Tianjin First Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Gao, MD

CONTACT

0086-13920128996; gaowei_tjfch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of Pediatric Organ Transplantation

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 27, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)