Immune Tolerance After Pediatric Liver transplantation-a Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Immunosuppressive (IS) agents are effective treatment to avoid acute or chronic rejection after pediatric liver transplantation. However, long-term side effect of IS intaking, like infection, kidney dysfunction, metabolic disorders and developmental retardation, should be aware, especially in pediatric recipients. Spontaneous immune tolerance is defined as recipients who cease to taking IS agents due to multiple reasons and the liver function maintained normal. However, the real ratio and safety of immune tolerance in pediatric liver transplantation recipients are rarely known. We would like to investigate the ratio and safety of spontaneous immune tolerance in pediatric liver transplantation recipients during long-term follow-up by constructing an immune tolerance cohort. In this cohort, long-term pediatric liver transplantation recipients with normal liver function and taking monotherapy of IS would be involved. The IS strategy would be monitored and adjusted according to the Clinical guidelines for pediatric liver transplantation in China(2015). For recipients suffering refractory virus infection, such as EBV or CMV infection, IS will be minimized to assist the clearance of virus until IS was weaned off. Since most of pediatric liver transplantation recipients may encounter chronic EBV or CMV infection within one year after transplantation, they may need IS minimization during follow-up. During the process of IS weaning off, liver function, immunological status and intrahepatic pathology will be closely monitored. If acute rejection or other complications were found, increase of IS dosage or other related treatments will be applied. Immune tolerance is defined as liver function and intrahepatic pathology maintain normal for more than one year after stop taking IS. At the end of study, the ratio of immune tolerance, acute rejection and all types of complications will be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: t
View:

• Age at liver transplantation: 4 months to 18 years;

• Original disease before liver transplantation: End-stage liver diseases including cholestatic diseases or metabolic diseases;

• Type of liver transplantation: living donor liver transplantation, with donors of recipient's parents

• Follow-up time after liver transplantation: more than one year

• Liver function: liver function maintains normal and stable 3 months before enrollment

• IS strategy: monotherapy of IS (FK or cyclosporine) or no longer taking any IS

• Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\<2)

• Written consents are required

Locations
Other Locations
China
Ren Ji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yuan Liu, MD
liuyuanbird@163.com
13651733680
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 200
Treatments
Immune tolerance cohort
Patients that are enrolled into this cohort will receive IS minimization if virus infection or side effects of IS was found. The strategy of IS minimization will follow the Clinical guidelines for pediatric liver transplantation in China(2015). Blood test and liver biopsy will be conducted to monitor liver function and intrahepatic pathological conditions. If IS is ceased for more than one year without liver dysfunction or signs of acute rejection in liver biopsy, immune tolerance was considered reached.
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov