Multiple SclerosisNCT05516303
Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
An observational study of Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Genetic polymorphism and Measurement of fingolimod and fingolimod-phosphate concentrations
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Sophie Nguyen, Msc, nguyen-s@chu-caen.fr
About this study
Official title: Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
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.
Read the 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
- Being tested
- Genetic polymorphism, Measurement of fingolimod and fingolimod-phosphate concentrations
- Keywords
- Fingolimod, hepatic adverse events, polymorphism
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic polymorphismGenetic
One blood tube will be taken for genetic testing
Measurement of fingolimod and fingolimod-phosphate concentrationsDiagnostic test
Measurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time
| Study group | Role | What they receive |
|---|---|---|
| Case | MS patients treated with fingolimod who experienced liver enzymes elevation Receives: Genetic: Genetic polymorphism; Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations | |
| Control | MS patients treated with fingolimod not experiencing elevated liver enzymes Receives: Genetic: Genetic polymorphism; Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP4F2 polymorphism frequency in case and control groups
Proportion of CYP4F2 polymorphism in case and control groups
Measured: At inclusion
Secondary outcomes (2)
Fingolimod concentrations in case and control groups
Trough concentration of fingolimod in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)
Measured: At inclusion
Fingolimod-phosphate concentrations in case and control groups
Trough concentration of fingolimod-phosphate in blood samples determined by liquid chromatography-tandem mass spectrometry (LC-MS)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start7 Jun 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Defer, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516303
- Sponsor's protocol ID
- 22-0041
- Status last verified
- May 2022
- First submitted
- 10 Jun 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
- ClinicalTrials.gov ID
- NCT05516303
- Acronym / sponsor ID
- 22-0041
- Conditions
- Multiple Sclerosis
- Keywords
- Fingolimod, hepatic adverse events, polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Genetic: Genetic polymorphism, Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrationsMS patients treated with fingolimod who experienced liver enzymes elevation |
| Control | – | Genetic: Genetic polymorphism, Diagnostic Test: Measurement of fingolimod and fingolimod-phosphate concentrationsMS patients treated with fingolimod not experiencing elevated liver enzymes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic polymorphismOne blood tube will be taken for genetic testing | Genetic | Case, Control |
| Measurement of fingolimod and fingolimod-phosphate concentrationsMeasurement of fingolimod and fingolimod-phosphate concentrations before usual drug administration time | Diagnostic test | Case, Control |
Primary outcome
CYP4F2 polymorphism frequency in case and control groups
Time frame: At inclusion
Proportion of CYP4F2 polymorphism in case and control groups
2 secondary outcomes
Fingolimod concentrations in case and control groups
Time frame: At inclusion
Fingolimod-phosphate concentrations in case and control groups
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Defer, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Nguyen, MSc (+33(0)231065127, nguyen-s@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CYP4F2 polymorphism frequency in case and control groups (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.