Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant

NCT ID: NCT03140462

Last Updated: 2021-08-11

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

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-21

Study Completion Date

2020-12-31

Brief Summary

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To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Detailed Description

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This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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liver transplant patients and donors

To study clinical and genetic factors on tacrolimus dose normalized trough concentration.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Living liver transplant during 20070101 \~ 20151231 and only received liver transplantation
* Lab data at least 8 months,
* Receiving tacrolimus as immunosuppressive drugs
* Transplantation at 20 \~ 65 years old

Exclusion Criteria

* Retransplantation or multi-organ transplantation
* Non-Asian
* Positive for human immunodeficiency virus.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rey-Heng Hu

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201612023RIND

Identifier Type: -

Identifier Source: org_study_id

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