The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMay 12, 2017
May 1, 2017
3.9 years
April 27, 2017
May 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Possibility of tacrolimus regimen guided by HLA matching rate
Changes of liver function and incidence of acute rejection early after liver transplantation
3 months
Secondary Outcomes (4)
Occurrence rate of GVHD
5 years
Occurrence time of adverse reactions caused by immune inhibitors
5 years
Degree of adverse reactions caused by immune inhibitors
5 years
Patient survival rate
1-year,3-year and 5-year
Study Arms (6)
research group,low MR group
EXPERIMENTALtacrolimus regimen guided by HLA matching rate
observation group,low MR group
NO INTERVENTIONtacrolimus regimen is applied according to clinical experience
research group,middle MR group
EXPERIMENTALtacrolimus regimen guided by HLA matching rate
observation group,middle MR group
NO INTERVENTIONtacrolimus regimen is applied according to clinical experience
research group,high MR group
EXPERIMENTALtacrolimus regimen guided by HLA matching rate
observation group,high MR group
NO INTERVENTIONtacrolimus regimen is applied according to clinical experience
Interventions
required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
Eligibility Criteria
You may qualify if:
- patients signed informed consent，patients with good compliance
You may not qualify if:
- autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
April 27, 2017
First Posted
May 10, 2017
Study Start
May 1, 2017
Primary Completion
April 1, 2021
Study Completion
April 1, 2025
Last Updated
May 12, 2017
Record last verified: 2017-05