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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02820259

Acronym

STABILE

Enrollment

Registered

2016-06-30

Start date

2016-05-01

Completion date

2017-04-07

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Concentration of Tacrolimus

Brief summary

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

Interventions

DRUGTacrolimus

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC	during the first 7 days after its initiation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026