NCT03800576

Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.

Detailed description

A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account. This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number：201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.

Conditions

• Liver Transplantation

Timeline

• Start date: 2019-06-06
• Primary completion: 2019-10-08
• Completion: 2020-09-22
• First posted: 2019-01-11
• Last updated: 2021-03-16

Locations

1 site across 1 country: Taiwan