NCT02752529

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Last Updated

May 2, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

March 30, 2016

Last Update Submit

April 28, 2016

Conditions

Cirrhosis, Liver

Keywords

Liver TransplantationIndividualized TherapyPolymorphism

Outcome Measures

Primary Outcomes (1)

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

    7 days

Study Arms (2)

Tacrolimus/dose1

EXPERIMENTAL

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

Drug: Tacrolimus（FK506）

Tacrolimus/dose2

ACTIVE COMPARATOR

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

Drug: Tacrolimus（FK506）

Interventions

Tacrolimus（FK506）DRUG
Tacrolimus/dose1Tacrolimus/dose2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30537010DERIVED

  • 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.

    PMID: 28941036DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhihai Peng

CONTACT

0086-13761010066pengzh1958@yeah.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of General Surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 27, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Last Updated

May 2, 2016

Record last verified: 2016-03

Locations

CN(1)