Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 10:37 PM
Study NCT ID:
NCT05516303
Status:
UNKNOWN
Last Update Posted:
2022-08-25
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011110', 'term': 'Polymorphism, Genetic'}], 'ancestors': [{'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CYP4F2 polymorphism frequency in case and control groups', 'timeFrame': 'At inclusion', 'description': 'Proportion of CYP4F2 polymorphism in case and control groups'}], 'secondaryOutcomes': [{'measure': 'Fingolimod concentrations in case and control groups', 'timeFrame': 'At inclusion', 'description': 'Trough concentration of fingolimod in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)'}, {'measure': 'Fingolimod-phosphate concentrations in case and control groups', 'timeFrame': 'At inclusion', 'description': 'Trough concentration of fingolimod-phosphate in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fingolimod', 'hepatic adverse events', 'polymorphism'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.', 'detailedDescription': 'PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not.\n\nOBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms.\n\nMETHOD OF RECRUITMENT:\n\nPatients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought.\n\nPROCEDURES:\n\nBlood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple sclerosis (MS) patients attending out-patient neurological consultations in Caen University Hospital, with a relapsing-remitting disease course, and prescribed fingolimod as a disease-modifying drug for MS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 years)\n* Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonald criteria)\n* Treated with fingolimod\n* Have given consent and signed an informed consent form\n\nExclusion Criteria:\n\n* an elevated liver test result on baseline before starting fingolimod treatment\n* presence of a viral, hereditary or auto-immune liver pathology\n* Time of fingolimod exposure lower than three months\n* Woman currently pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05516303', 'briefTitle': 'Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod', 'orgStudyIdInfo': {'id': '22-0041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'MS patients treated with fingolimod who experienced liver enzymes elevation', 'interventionNames': ['Genetic: Genetic polymorphism', 'Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations']}, {'label': 'Control', 'description': 'MS patients treated with fingolimod not experiencing elevated liver enzymes', 'interventionNames': ['Genetic: Genetic polymorphism', 'Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations']}], 'interventions': [{'name': 'Genetic polymorphism', 'type': 'GENETIC', 'description': 'One blood tube will be taken for genetic testing', 'armGroupLabels': ['Case', 'Control']}, {'name': 'Measurement of fingolimod and fingolimod-phosphate concentrations', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Nguyen, Msc', 'role': 'CONTACT', 'email': 'nguyen-s@chu-caen.fr'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Sophie Nguyen, MSc', 'role': 'CONTACT', 'email': 'nguyen-s@chu-caen.fr', 'phone': '+33(0)231065127'}], 'overallOfficials': [{'name': 'Gilles Defer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}