NCT05516303

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

Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
GENETIC	Genetic polymorphism	One blood tube will be taken for genetic testing
DIAGNOSTIC_TEST	Measurement of fingolimod and fingolimod-phosphate concentrations	Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time

Timeline

• Start date: 2022-06-07
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-08-25
• Last updated: 2022-08-25

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study