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

NCT05516303 | Unknown FDA Drug

• 1 other identifier: 22-0041
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Fingolimod; hepatic adverse events; polymorphism

Outcome Measures

Primary Outcomes (1)

• CYP4F2 polymorphism frequency in case and control groups

  Proportion of CYP4F2 polymorphism in case and control groups

  At inclusion

Secondary Outcomes (2)

• Fingolimod concentrations in case and control groups

  At inclusion

• Fingolimod-phosphate concentrations in case and control groups

  At inclusion

Study Arms (2)

Case

MS patients treated with fingolimod who experienced liver enzymes elevation

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

Control

MS patients treated with fingolimod not experiencing elevated liver enzymes

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

Interventions

Genetic polymorphism GENETIC

One blood tube will be taken for genetic testing

Case; Control

Measurement of fingolimod and fingolimod-phosphate concentrations DIAGNOSTIC_TEST

Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis (MS) patients attending out-patient neurological consultations in Caen University Hospital, with a relapsing-remitting disease course, and prescribed fingolimod as a disease-modifying drug for MS.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Polymorphism, Genetic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena

Study Officials

• Gilles Defer, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Nguyen, MSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: August 25, 2022
• Study Start: June 7, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-05

Locations

FR (1)