The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation

Not Applicable

Not yet recruiting

• Conditions: Liver Transplantation; Graft Versus Host Disease; Graft Rejection; Drug-Related Side Effects and Adverse Reactions
• Interventions: Other: tacrolimus regimen guided by HLA matching rate

• Registration Number: NCT03147157
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Detailed Description

Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Study Timeline

• Study First Submitted: 2017-04-27
• Status Verified: 2017-05
• Study Start: 2017-05
• Study First Submitted QC: 2017-05-06
• Study First Posted: 2017-05-10
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2021-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients signed informed consent，patients with good compliance

Exclusion Criteria

• autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
research group,middle MR group	tacrolimus regimen guided by HLA matching rate	tacrolimus regimen guided by HLA matching rate
research group,high MR group	tacrolimus regimen guided by HLA matching rate	tacrolimus regimen guided by HLA matching rate
research group,low MR group	tacrolimus regimen guided by HLA matching rate	tacrolimus regimen guided by HLA matching rate

Primary Outcome Measures

Name	Time	Method
Possibility of tacrolimus regimen guided by HLA matching rate	3 months	Changes of liver function and incidence of acute rejection early after liver transplantation

Secondary Outcome Measures

Name	Time	Method
Occurrence rate of GVHD	5 years	Occurrence rate of GVHD between the different groups
Occurrence time of adverse reactions caused by immune inhibitors	5 years	Occurrence time of adverse reactions caused by immune inhibitors between the different groups
Patient survival rate	1-year,3-year and 5-year	Patient survival rate between the different groups
Degree of adverse reactions caused by immune inhibitors	5 years	Degree of adverse reactions caused by immune inhibitors between the different groups