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NCT03140462 Clinical Trial

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

Liver Transplantation Clinical Trial

Official title:
The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03140462
Other study ID # 201612023RIND
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2017
Est. completion date December 31, 2020

Study information
Verified date December 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date December 31, 2020
Est. primary completion date April 12, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:donors' recipients - 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: donors' recipients - Retransplantation or multi-organ transplantation - Non-Asian - Positive for human immunodeficiency virus.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight. Within the first 6 months post-transplantation
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