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NCT02752529 Clinical Trial

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

Cirrhosis, Liver Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02752529
Other study ID # PZhihai
Secondary ID
Status Recruiting
Phase N/A
First received March 30, 2016
Last updated April 28, 2016
Start date March 2016

Study information
Verified date March 2016
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Zhihai Peng
Phone 0086-13761010066
Email pengzh1958@yeah.net
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 415
Est. completion date
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus(FK506)

Locations
Country Name City State
China Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) of Tacrolimus 7 days No
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