Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
NCT ID: NCT05516303
Last Updated: 2022-08-25
Study Results
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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UNKNOWN
65 participants
OBSERVATIONAL
2022-06-07
2022-10-31
Brief Summary
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Detailed Description
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OBJECTIVE: 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.
METHOD OF RECRUITMENT:
Patients 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.
PROCEDURES:
Blood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Case
MS patients treated with fingolimod who experienced liver enzymes elevation
Genetic polymorphism
One blood tube will be taken for genetic testing
Measurement of fingolimod and fingolimod-phosphate concentrations
Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time
Control
MS patients treated with fingolimod not experiencing elevated liver enzymes
Genetic polymorphism
One blood tube will be taken for genetic testing
Measurement of fingolimod and fingolimod-phosphate concentrations
Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time
Interventions
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Genetic polymorphism
One blood tube will be taken for genetic testing
Measurement of fingolimod and fingolimod-phosphate concentrations
Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time
Eligibility Criteria
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Inclusion Criteria
* Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonald criteria)
* Treated with fingolimod
* Have given consent and signed an informed consent form
Exclusion Criteria
* presence of a viral, hereditary or auto-immune liver pathology
* Time of fingolimod exposure lower than three months
* Woman currently pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Principal Investigators
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Gilles Defer, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
Locations
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Caen University Hospital
Caen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-0041
Identifier Type: -
Identifier Source: org_study_id
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