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RECRUITING
NCT06359782
PHASE2

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)

Sponsor: Haaglanden Medical Centre

View on ClinicalTrials.gov

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.

Official title: A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2024-11-04

Completion Date

2027-03

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DRUG

C1 Esterase Inhibitor Injection [Cinryze]

C1 Esterase Inhibitor Injection \[Cinryze\]

DRUG

Placebo

Sodium Chloride /physiological saline (0.9%) in equal volume dosed intravenous

Locations (1)

Haaglanden Medical Centre

The Hague, South Holland, Netherlands