Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)

N/ACompletedNCT02820259

Rennes University Hospital42 enrolled

Overview

The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Biliary Concentration of Tacrolimus

Interventions

TacrolimusDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (\> 18 years) of both sexes, * Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, * Not having expressed their opposition to participation in the study Exclusion Criteria: * Bilio-enteric anastomosis, * Associated transplantation of another organ * Contraindications to TCR administration * Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.

Locations (1)

Centre hospitalier universitaire de Rennes

Rennes, France

Outcomes

Primary Outcomes

coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC

Time frame: during the first 7 days after its initiation

Data from ClinicalTrials.gov

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