Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690711
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-12-27
Brief Title:
A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction
Sponsor:
Beijing Suncadia Pharmaceuticals Co Ltd
Organization:
Beijing Suncadia Pharmaceuticals Co Ltd
Study Overview
Official Title:
Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction a Randomised Double-blind Placebo-controlled Phase II Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The primary objective is to explore if HRS8179 could improve midline shift at 72 hours or at time of decompressive craniectomy or comfort measures only if earlier in participants with large hemispheric infarction The secondary objective is to explore if HRS8179 could improve acute neurologic status functional outcomes treatment requirements and safety
Detailed Description:
None
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