Status:
COMPLETED
Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria
Lead Sponsor:
Biocodex
Conditions:
Primary Hyperoxaluria
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria. Pilot clinical study, open, prospective and multicenter.
Eligibility Criteria
Inclusion
- Patient with primary hyperoxaluria type 1, 2 or 3, diagnosed according to standard methods
- Having at least one molar ratio \[oxaluria / creatinuria\] greater than 0.08 since diagnosis
- Having Glomerular Filtration Rate ≥ 45 mL / min / 1.73m2
- Age ≥ 6 months
- Having read, or whose parents have read, the information note and signed the consent form. For children, if their level of understanding allows, their assent will also be sought
- Proficient enough, or whose parents or legal representatives have sufficient mastery, the French language to read, understand and complete study documents
- Affiliate or beneficiary of a social security scheme
- Ability to respect the protocol, including treatment, and can be followed regularly in the study
- For pubertal patients, contraception deemed effective by the investigator or abstinence
Exclusion
- Introduction, discontinuation or dose modification of vitamin B6 or potassium citrate treatment within 4 weeks prior to the inclusion visit
- Consumption of jelly candies and / or dark chocolate in the week preceding the study
- Patient having a kidney and / or liver transplant
- Presence of a clinically significant acute or chronic pathology, other than primary hyperoxaluria, that may interfere with the evaluation of the study results according to the investigator
- During biological or physical examinations, presence of significant anomaly (s) inconsistent with participation in the study according to the investigator
- History of severe allergy, asthma, skin rash or hypersensitivity to a drug
- Treatment affecting hepatic metabolism (cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin) in progress or taken during the month preceding the start of the study
- Treatment affecting the renal tubule (probenecid, β-lactams, ...) in progress or taken during the last two weeks preceding the start of the study
- Presence of a pathology or treatment that, according to the investigator, renders the subject unfit
- Contraindications to stiripentol as defined in the current SmPC (hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC, history of psychosis in the form of delusional episodes)
- Pregnant or lactating woman
- Patient under guardianship
- Patient concurrently participating in another clinical trial or exclusion period following a previous trial
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03819647
Start Date
May 21 2019
End Date
March 8 2021
Last Update
March 26 2021
Active Locations (3)
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1
Hôpital Necker
Paris, France
2
Hôpital Robert Debré
Paris, France
3
Hôpital Tenon
Paris, France