Influence of Genetic Polymorphism of Donor on Tacrolimus... | NCT03140462

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

NCT03140462

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Aug 11, 2021Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Liver Transplantation

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2017Actual

Primary Completion Date

Apr 12, 2018Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Apr 24, 2017

First Submission Date that Met QC Criteria

May 3, 2017

First Posted Date

May 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2021

Last Update Posted Date

Aug 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liver transplant patients and donors		To study clinical and genetic factors on tacrolimus dose normalized trough concentration.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

liver transplant patients' donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rey-Heng Hu	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		10050	Taiwan
National Taiwan University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided