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

NCT05516303 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2022-08-25

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Gilles Defer, MD · University Hospital, Caen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516303 on ClinicalTrials.gov