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

NCT ID: NCT03147157

Last Updated: 2017-05-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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research group,low MR group

tacrolimus regimen guided by HLA matching rate

Group Type EXPERIMENTAL

tacrolimus regimen guided by HLA matching rate

Intervention Type OTHER

required low,middle and high tacrolimus concentration in high,middle and low MR group respectively

observation group,low MR group

tacrolimus regimen is applied according to clinical experience

Group Type NO_INTERVENTION

No interventions assigned to this group

research group,middle MR group

tacrolimus regimen guided by HLA matching rate

Group Type EXPERIMENTAL

tacrolimus regimen guided by HLA matching rate

Intervention Type OTHER

required low,middle and high tacrolimus concentration in high,middle and low MR group respectively

observation group,middle MR group

tacrolimus regimen is applied according to clinical experience

Group Type NO_INTERVENTION

No interventions assigned to this group

research group,high MR group

tacrolimus regimen guided by HLA matching rate

Group Type EXPERIMENTAL

tacrolimus regimen guided by HLA matching rate

Intervention Type OTHER

required low,middle and high tacrolimus concentration in high,middle and low MR group respectively

observation group,high MR group

tacrolimus regimen is applied according to clinical experience

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tacrolimus regimen guided by HLA matching rate

required low,middle and high tacrolimus concentration in high,middle and low MR group respectively

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients signed informed consent,patients with good compliance

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Guoyue Lv

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LCPYJJ2017007

Identifier Type: -

Identifier Source: org_study_id

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