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

NCT ID: NCT02752529

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis, Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tacrolimus/dose1

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

Group Type EXPERIMENTAL

Tacrolimus(FK506)

Intervention Type DRUG

Tacrolimus/dose2

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

Group Type ACTIVE_COMPARATOR

Tacrolimus(FK506)

Intervention Type DRUG

Interventions

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Tacrolimus(FK506)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Peng Zhihai

Director, Head of General Surgery, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihai Peng

Role: CONTACT

0086-13761010066

Facility Contacts

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Zhihai Peng

Role: primary

0086-13761010066

References

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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.

Reference Type DERIVED
PMID: 30537010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28941036 (View on PubMed)

Other Identifiers

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PZhihai

Identifier Type: -

Identifier Source: org_study_id

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