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UNKNOWNNCT05516303

Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

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 ...

Lead sponsor: University Hospital, Caen•1 locations•View source on ClinicalTrials.gov

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Contacts

Sophie Nguyen, MSc

CONTACT

+33(0)231065127 nguyen-s@chu-caen.fr

Sponsors

Lead Sponsor

University Hospital, Caen

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. 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Adults (\> 18 years)
•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

•an elevated liver test result on baseline before starting fingolimod treatment
•presence of a viral, hereditary or auto-immune liver pathology
•Time of fingolimod exposure lower than three months
•Woman currently pregnant or breastfeeding

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 25, 2022Terms

Trial snapshot

StatusUNKNOWN

Phase—

Enrollment65

Start dateJun 2022

Last updatedAug 25, 2022

Condition

Multiple Sclerosis

Locations shown

Caen University Hospital

Caen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2022Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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