Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465472
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-03
Brief Title:
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1 2 or 3
Sponsor:
Biocodex
Organization:
Biocodex
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1 2 or 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYSTAL
Brief Summary:
Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1 2 or 3
Detailed Description:
A multicenter randomized double-blind placebo-controlled phase 3 study The study is designed to compare the efficacy of stiripentol to a placebo in patients 6 years and older with primary hyperoxaluria type 1 2 or 3
The study will be conducted in 2 periods a 6-month placebo-controlled double-blind treatment period period 1 followed by a 6-month open-label treatment period with blind maintained on results period 2
Patients who benefit from the treatment after the first 12 months of study treatment will be proposed to enter the open-label extension OLE part of the study to continue to assess the long-term efficacy and safety of stiripentol
The study will be conducted in 2 periods a 6-month placebo-controlled double-blind treatment period period 1 followed by a 6-month open-label treatment period with blind maintained on results period 2
Patients who benefit from the treatment after the first 12 months of study treatment will be proposed to enter the open-label extension OLE part of the study to continue to assess the long-term efficacy and safety of stiripentol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508062-15-00 | CTIS | None | None |