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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;

• Age ≥ 18 years on admission;

• WFNS grade 1-5.

Locations
Other Locations
Netherlands
Haaglanden Medical Centre
RECRUITING
The Hague
Contact Information
Primary
Daan de Groot, MD
daan.de.groot@haaglandenmc.nl
088 979 7900
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 128
Treatments
Experimental: C1-esterase inhibitor (Cinryze)
One group receiving study medication (C1-esterase inhibitor Cinryze)
Placebo_comparator: Placebo
One group receiving placebo medication
Related Therapeutic Areas
Sponsors
Leads: Haaglanden Medical Centre
Collaborators: Takeda, Leiden University Medical Center

This content was sourced from clinicaltrials.gov