Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
NCT ID: NCT06147375
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
47 participants
INTERVENTIONAL
2023-12-01
2028-12-31
Brief Summary
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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.
Detailed Description
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Methods:The study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal IS after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of IS withdrawal.In this study, we will 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.
Protocol after enrollment: After enrollment,the recipients will take IS withdrawal follow the protocol of this study.The IS withdrawal protocol is once daily for weeks 1 to 4, then decreased every 4 weeks until the IS is totally stopped by 25 weeks. Following enrollment, recipients will be examined at several time periods such as peripheral blood tests,liver function , liver biopsy, and other relevant indicators to determine IS withdrawal and adverse effects.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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immunosuppressive withdrawal
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
ALL
No
Sponsors
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Wei Gao
OTHER
Responsible Party
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Wei Gao
Head of Department of Pediatric Organ Transplantation
Principal Investigators
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Wei Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin First Central Hospital
Locations
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Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023DZX32
Identifier Type: -
Identifier Source: org_study_id