Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-04-19 @ 12:14 AM
Study NCT ID:
NCT03147157
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-06', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Possibility of tacrolimus regimen guided by HLA matching rate', 'timeFrame': '3 months', 'description': 'Changes of liver function and incidence of acute rejection early after liver transplantation'}], 'secondaryOutcomes': [{'measure': 'Occurrence rate of GVHD', 'timeFrame': '5 years', 'description': 'Occurrence rate of GVHD between the different groups'}, {'measure': 'Occurrence time of adverse reactions caused by immune inhibitors', 'timeFrame': '5 years', 'description': 'Occurrence time of adverse reactions caused by immune inhibitors between the different groups'}, {'measure': 'Degree of adverse reactions caused by immune inhibitors', 'timeFrame': '5 years', 'description': 'Degree of adverse reactions caused by immune inhibitors between the different groups'}, {'measure': 'Patient survival rate', 'timeFrame': '1-year,3-year and 5-year', 'description': 'Patient survival rate between the different groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tacrolimus', 'histocompatibility antigens'], 'conditions': ['Liver Transplantation', 'Graft Versus Host Disease', 'Graft Rejection', 'Drug-Related Side Effects and Adverse Reactions']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients signed informed consent，patients with good compliance\n\nExclusion Criteria:\n\n* autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation'}, 'identificationModule': {'nctId': 'NCT03147157', 'briefTitle': 'The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen', 'orgStudyIdInfo': {'id': 'LCPYJJ2017007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'research group,low MR group', 'description': 'tacrolimus regimen guided by HLA matching rate', 'interventionNames': ['Other: tacrolimus regimen guided by HLA matching rate']}, {'type': 'NO_INTERVENTION', 'label': 'observation group,low MR group', 'description': 'tacrolimus regimen is applied according to clinical experience'}, {'type': 'EXPERIMENTAL', 'label': 'research group,middle MR group', 'description': 'tacrolimus regimen guided by HLA matching rate', 'interventionNames': ['Other: tacrolimus regimen guided by HLA matching rate']}, {'type': 'NO_INTERVENTION', 'label': 'observation group,middle MR group', 'description': 'tacrolimus regimen is applied according to clinical experience'}, {'type': 'EXPERIMENTAL', 'label': 'research group,high MR group', 'description': 'tacrolimus regimen guided by HLA matching rate', 'interventionNames': ['Other: tacrolimus regimen guided by HLA matching rate']}, {'type': 'NO_INTERVENTION', 'label': 'observation group,high MR group', 'description': 'tacrolimus regimen is applied according to clinical experience'}], 'interventions': [{'name': 'tacrolimus regimen guided by HLA matching rate', 'type': 'OTHER', 'description': 'required low,middle and high tacrolimus concentration in high,middle and low MR group respectively', 'armGroupLabels': ['research group,high MR group', 'research group,low MR group', 'research group,middle MR group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Guoyue Lv', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}