Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-04 @ 10:44 AM
Study NCT ID:
NCT02820259
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-21', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC', 'timeFrame': 'during the first 7 days after its initiation'}]}, 'conditionsModule': {'conditions': ['Biliary Concentration of Tacrolimus']}, 'referencesModule': {'references': [{'pmid': '30467013', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'liver-transplanted patients who receive tacrolimus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 18 years) of both sexes,\n* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,\n* Not having expressed their opposition to participation in the study\n\nExclusion Criteria:\n\n* Bilio-enteric anastomosis,\n* Associated transplantation of another organ\n* Contraindications to TCR administration\n* Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.'}, 'identificationModule': {'nctId': 'NCT02820259', 'acronym': 'STABILE', 'briefTitle': 'Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)', 'orgStudyIdInfo': {'id': '35RC16_9755'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre hospitalier universitaire de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}