The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter
Not Applicable
- Conditions
- Cirrhosis, Liver
- Interventions
- Drug: Tacrolimus（FK506）
- Registration Number
- NCT02752529
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 415
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus/dose1 Tacrolimus（FK506） Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days Tacrolimus/dose2 Tacrolimus（FK506） Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of Tacrolimus 7 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China