*CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept*

Phase 2

Completed

• Conditions: Hemorrhagic stroke; Stroke; 10007963; 10002363

• Registration Number: NL-OMON48636
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-02-19
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1) Confirmed aneurysmal subarachnoid hemorrhage (SAH)
2) Admission to either the UMCU or Erasmus MC within 11.5 hours after ictus
3) Age 18 years and older

Exclusion Criteria

1) Life expectancy < 10 days;
2) Pregnant or breast-feeding women;
3) Participation in another clinical therapeutic study;
4) History of splenectomy or asplenia (potentially increased risk of
meningococcal infection);
5) Hematologic malignancy;
6) Patients receiving chemotherapy;
7) Patients who will undergo or underwent an organ transplantation;
8) Patients with myasthenia gravis, glucose-6-phosphate dehydrogenase
(G6PD) deficiency, or tuberculosis;
9) Patients who are or will be treated by plasmapheresis or
hemodialysis;
10) Patient with a creatinine clearance of <30 or serum creatinine levels
of >169 µmol/l
11) Patients with a known hereditary complement deficiency;
12) Patients allergic to eculizumab, proteins derived from mouse
products or other monoclonal antibodies;
13) Patients allergic to (prophylactic) antibiotic treatment for Neisseria
meningitidis (quinolones or ceftriaxone (therapeutic));
14) If on admission, it is likely that the aneurysm can only be treated
with extracranial-intracranial bypass surgery;
15) If based on head imaging, it will be unlikely that CSF can be obtained
48-72 hours after ictus;
16) Patients with an ongoing infection on admission which is not
appropriately treated;
17) Patients who were treated >4 times with antibiotics during the last
year;
18) Patients on immunosuppressive therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is biological effectivity determined by the<br /><br>concentration of C5a in CSF. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are the occurrence of adverse events (AEs) and<br /><br>serious adverse events (SAEs), plasma and CSF parameters of inflammation,<br /><br>quality of life (QoL), functional, and cognitive outcomes, and the presence and<br /><br>volume of cerebral infarction. </p><br>