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

Last updated: August 23, 2022
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT05516303
22-0041
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (> 18 years)
  • Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonaldcriteria)
  • Treated with fingolimod
  • Have given consent and signed an informed consent form

Exclusion

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

Study Design

Total Participants: 65
Study Start date:
June 07, 2022
Estimated Completion Date:
October 31, 2022

Study 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

Connect with a study center

  • Caen University Hospital

    Caen, 14000
    France

    Active - Recruiting

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