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

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