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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-04-07

Brief Summary

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

Detailed Description

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Conditions

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Biliary Concentration of Tacrolimus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tacrolimus

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre hospitalier universitaire de Rennes

Rennes, , France

Site Status

Countries

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France

References

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Rayar M, Tron C, Locher C, Chebaro A, Beaurepaire JM, Blondeau M, Cusumano C, Bardou-Jacquet E, Houssel-Debry P, Camus C, Petitcollin A, Verdier MC, Lakehal M, Desfourneaux V, Sulpice L, Meunier B, Bellissant E, Boudjema K, Lemaitre F. Tacrolimus Concentrations Measured in Excreted Bile in Liver Transplant Recipients: The STABILE Study. Clin Ther. 2018 Dec;40(12):2088-2098. doi: 10.1016/j.clinthera.2018.10.015. Epub 2018 Nov 19.

Reference Type DERIVED

PMID: 30467013 (View on PubMed)

Other Identifiers

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35RC16_9755

Identifier Type: -

Identifier Source: org_study_id