Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582524
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Pegzilarginase in Subjects 24 Months Old With Arginase 1 Deficiency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Open-Label Study of Safety Pharmacokinetics and Activity of Weekly Subcutaneous Pegzilarginase in Subjects 24 Months Old With Arginase 1 Deficiency
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicentre study to evaluate the safety PK and activity PD of weekly subcutaneous SC administration of pegzilarginase in subjects with ARG1-D who are 24 months of age The study consists of a screening period of up to 4 weeks a subsequent 12-week treatment period and a safety follow-up period of 8 weeks
Detailed Description:
CAEB1102-301A is an open-label single-arm non-controlled repeat dosing multicentre study to evaluate the safety PK and activity PD of weekly SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are 24 months of age
This study will consist of
A screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine
A treatment period of 12 weeks
A safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose
This study will consist of
A screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine
A treatment period of 12 weeks
A safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None