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

J

Jilin University

Status

Not yet enrolling

Conditions

Graft Versus Host Disease
Liver Transplantation
Drug-Related Side Effects and Adverse Reactions
Graft Rejection

Treatments

Other: tacrolimus regimen guided by HLA matching rate

Study type

Interventional

Funder types

Other

Identifiers

NCT03147157
LCPYJJ2017007

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients signed informed consent,patients with good compliance

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 6 patient groups

research group,low MR group
Experimental group
Description:
tacrolimus regimen guided by HLA matching rate
Treatment:
Other: tacrolimus regimen guided by HLA matching rate
observation group,low MR group
No Intervention group
Description:
tacrolimus regimen is applied according to clinical experience
research group,middle MR group
Experimental group
Description:
tacrolimus regimen guided by HLA matching rate
Treatment:
Other: tacrolimus regimen guided by HLA matching rate
observation group,middle MR group
No Intervention group
Description:
tacrolimus regimen is applied according to clinical experience
research group,high MR group
Experimental group
Description:
tacrolimus regimen guided by HLA matching rate
Treatment:
Other: tacrolimus regimen guided by HLA matching rate
observation group,high MR group
No Intervention group
Description:
tacrolimus regimen is applied according to clinical experience

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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