NCT03800576

Brief Summary

Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

March 16, 2021

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 9, 2019

Last Update Submit

March 14, 2021

Conditions

Liver Transplantation

Keywords

tacrolimusliver transplantgene polymorphismimmunosuppressant

Outcome Measures

Primary Outcomes (2)

  • Incidence of patients with biopsy proven acute rejection (BPAR)

    Incidence of BPAR will be estimated with Kaplan-Meier analysis

    up to 12 months after liver transplantation

  • Graft survival

    incidence of graft loss will be estimated Kaplan-Meier analysis

    up to 9 years after liver transplantation

Secondary Outcomes (2)

  • Number of patients with tacrolimus-associated adverse events

    up to 9 years after liver transplantation

  • Patient survival

    up to 9 years after liver transplantation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in National Taiwan University Hospital and received tacrolimus-based immunosuppression.

You may qualify if:

  • patients who underwent living-donor liver transplantation during January 2008 to December 2017
  • at the age of 20-65
  • with tacrolimus-based immunosuppression after liver transplant for at least 6 months.

You may not qualify if:

  • retransplantation
  • multi-organ transplantation
  • human immunodeficiency virus (HIV) positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Rey-Heng Hu, Professor

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

June 6, 2019

Primary Completion

October 8, 2019

Study Completion

September 22, 2020

Last Updated

March 16, 2021

Record last verified: 2020-01

Locations

TW(1)