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OpenTrials
Completed

NCT Number: NCT02820259

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

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

Completed

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Key information

Conditions

Biliary Concentration of Tacrolimus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Rennes

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

Primary outcomes

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

    Time frame: during the first 7 days after its initiation

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: STABILE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2016
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.