Trials / Unknown
UnknownNCT03147157
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- The First Hospital of Jilin University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Liver Transplantation
- Graft Versus Host Disease
- Graft Rejection
- Drug-Related Side Effects and Adverse Reactions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | tacrolimus regimen guided by HLA matching rate | required low,middle and high tacrolimus concentration in high,middle and low MR group respectively |
Timeline
- Start date
- 2017-05-01
- Primary completion
- 2021-04-01
- Completion
- 2025-04-01
- First posted
- 2017-05-10
- Last updated
- 2017-05-12
Source: ClinicalTrials.gov record NCT03147157. Inclusion in this directory is not an endorsement.