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

C

Caen University Hospital

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Genetic: Genetic polymorphism
Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations

Study type

Observational

Funder types

Other

Identifiers

NCT05516303
22-0041

Details and patient eligibility

About

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.

Full description

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

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

Case
Description:
MS patients treated with fingolimod who experienced liver enzymes elevation
Treatment:
Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations
Genetic: Genetic polymorphism
Control
Description:
MS patients treated with fingolimod not experiencing elevated liver enzymes
Treatment:
Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations
Genetic: Genetic polymorphism

Trial contacts and locations

0

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Central trial contact

Sophie Nguyen, MSc

Data sourced from clinicaltrials.gov

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