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The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter

Primary Purpose

Cirrhosis, Liver

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tacrolimus（FK506）
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Liver Transplantation, Individualized Therapy, Polymorphism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of end-tage liver diseases
  • 18 years old or above
  • Han nationality
  • Therapeutic regimen：TAC

Exclusion Criteria:

  • Less than 18 years old
  • Other races
  • Therapeutic regimen：cyclosporine

Sites / Locations

  • Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tacrolimus/dose1

Tacrolimus/dose2

Arm Description

Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days

Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of Tacrolimus

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
April 28, 2016
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02752529
Brief Title
The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

5. Study Description

Brief Summary
Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506 metabolic differences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
Keywords
Liver Transplantation, Individualized Therapy, Polymorphism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
415 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus/dose1
Arm Type
Experimental
Arm Description
Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days
Arm Title
Tacrolimus/dose2
Arm Type
Active Comparator
Arm Description
Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Tacrolimus（FK506）
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of Tacrolimus
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of end-tage liver diseases 18 years old or above Han nationality Therapeutic regimen：TAC Exclusion Criteria: Less than 18 years old Other races Therapeutic regimen：cyclosporine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihai Peng
Phone
0086-13761010066
Email
pengzh1958@yeah.net
Facility Information:
Facility Name
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihai Peng
Phone
0086-13761010066
Email
pengzh1958@yeah.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
30537010
Citation
Ou B, Liu Y, Zhang T, Sun Y, Chen J, Peng Z. TLR9 rs352139 Genetic Variant Promotes Tacrolimus Elimination in Chinese Liver Transplant Patients During the Early Posttransplantation Period. Pharmacotherapy. 2019 Jan;39(1):67-76. doi: 10.1002/phar.2204. Epub 2019 Jan 8.
Results Reference
derived
PubMed Identifier
28941036
Citation
Zhang T, Liu Y, Zeng R, Ling Q, Wen P, Fan J, Peng Z. Association of donor small ubiquitin-like modifier 4 rs237025 genetic variant with tacrolimus elimination in the early period after liver transplantation. Liver Int. 2018 Apr;38(4):724-732. doi: 10.1111/liv.13597. Epub 2017 Oct 4.
Results Reference
derived

Learn more about this trial

The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter

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