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

NCT ID: NCT06359782

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, multicenter, randomized, double-blind, placebo-controlled, phase II trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C1-esterase inhibitor (Cinryze)

One group receiving study medication (C1-esterase inhibitor Cinryze)

Group Type EXPERIMENTAL

C1 Esterase Inhibitor Injection [Cinryze]

Intervention Type DRUG

C1 Esterase Inhibitor Injection \[Cinryze\]

Placebo

One group receiving placebo medication

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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C1 Esterase Inhibitor Injection [Cinryze]

C1 Esterase Inhibitor Injection \[Cinryze\]

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cinryze

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;
* Age ≥ 18 years on admission;
* WFNS grade 1-5.

Exclusion Criteria

* Subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome)
* Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous)
* Participation in another clinical therapeutic study;
* Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
* Patients with a known hereditary complement deficiency (including hereditary angioedema);
* Patients with a history of sensibility to blood products or C1-inhibitor;
* Patients with a history of thrombosis (when known at time of inclusion);
* Pregnant woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role collaborator

Haaglanden Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Wouter Moojen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wouter Moojen, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Haaglanden Medisch Centrum

Locations

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Haaglanden Medical Centre

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Daan de Groot, MD

Role: CONTACT

Phone: 088 979 7900

Email: [email protected]

Facility Contacts

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Daan de Groot, MD

Role: primary

Other Identifiers

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NL76082.058.20

Identifier Type: -

Identifier Source: org_study_id