Not Yet RecruitingPhase 3

Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3

42 participantsStarted 2024-08

Plain-language summary

Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2 or 3.

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\> 2 × upper limit of normal (ULN)
✕. Total bilirubin \> 1.5 x ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is \< 2 x ULN

% change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) determined from 24-hour urine sample collections

Timeframe: % change in 24-hour urinary oxalate excretion between baseline value and value at month 6

NCT IDNCT06465472

SponsorBiocodex

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-08

Pauline DECIMA