Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359782
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-22
Brief Title:
Complement Inhibition Attacking the Overshooting Inflammation Fter Subarachnoid Hemorrhage CIAOSAH
Sponsor:
Haaglanden Medical Centre
Organization:
Haaglanden Medical Centre
Study Overview
Official Title:
A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
CIAOSAH
Brief Summary:
Aneurysmal subarachnoid hemorrhage SAH can lead to devastating outcomes for patients like cognitive decline This is caused by early brain injury EBI followed by delayed cerebral ischemia DCI Neuroinflammation triggered by the complement system has been investigated to be a key mediator in the pathophysiology of EBI and DCI Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH
This trial aims to study the safety and efficacy of C1-inhibitor Cinryze an approved inhibitor of the complement system compared to placebo in patients with SAH By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response
This trial aims to study the safety and efficacy of C1-inhibitor Cinryze an approved inhibitor of the complement system compared to placebo in patients with SAH By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None