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

NCT06359782 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

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

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Takeda

    collaborator INDUSTRY

  • Haaglanden Medical Centre

    lead OTHER

Principal Investigators

  • Wouter Moojen, MD PHD · Haaglanden Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359782 on ClinicalTrials.gov