Clinical trial NCT03147157: The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
Official title: The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Graft Versus Host Disease
Graft Rejection
Drug-Related Side Effects and Adverse Reactions
Keywords: tacrolimus
histocompatibility antigens
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients signed informed consent，patients with good compliance

Exclusion Criteria:

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

Primary outcomes:
measure: Possibility of tacrolimus regimen guided by HLA matching rate
timeFrame: 3 months
Secondary outcomes:
measure: Occurrence rate of GVHD
timeFrame: 5 years
measure: Occurrence time of adverse reactions caused by immune inhibitors
timeFrame: 5 years
measure: Degree of adverse reactions caused by immune inhibitors
timeFrame: 5 years
measure: Patient survival rate
timeFrame: 1-year,3-year and 5-year
Other outcomes:
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