Clinical trial • Phase II • Neurology

C1 esterase inhibitor (human) for Aneurysmal subarachnoid hemorrhage

Phase II trial of C1 esterase inhibitor (human) for Aneurysmal subarachnoid hemorrhage.

Overview

Trial Therapeutic Area: Neurology
Trial Disease: Aneurysmal subarachnoid hemorrhage
Trial Stage: Phase II
Drug Modality: Peptide/protein/enzyme | Small molecule

Key dates

Initial CTIS Submission Date: 16-01-2025
First CTIS Authorization Date: 27-01-2025

Trial design

Test: Cinryze 500 IU powder and solvent for solution for injection (C1 esterase inhibitor (human), IV infusion; product shows maxDailyDoseAmount 6000 IU). Comparator/placebo: Sodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion (IV infusion; product information lists dose units mmol/kg with maxDailyDoseAmount 6 mmol/kg).-controlled Phase II trial across 1 site in Netherlands.

Comparator: Test: Cinryze 500 IU powder and solvent for solution for injection (C1 esterase inhibitor (human), IV infusion; product shows maxDailyDoseAmount 6000 IU). Comparator/placebo: Sodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion (IV infusion; product information lists dose units mmol/kg with maxDailyDoseAmount 6 mmol/kg).
Target Sample Size: 128

Eligibility

Recruits 128 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent documents include 'L1_SIS and ICF patient' and 'L1_SIS and ICF representative', indicating provision for consent by a legal representative where required. Age inclusion is 18 years or above so no paediatric assent arrangements are indicated in the available records..

Pregnancy Exclusion: Pregnant women
Vulnerable Population: Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent documents include 'L1_SIS and ICF patient' and 'L1_SIS and ICF representative', indicating provision for consent by a legal representative where required. Age inclusion is 18 years or above so no paediatric assent arrangements are indicated in the available records.

Inclusion criteria

{"criterion_text":"- Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan"}
{"criterion_text":"- Age of 18 years or above"}
{"criterion_text":"- WFNS grade 1-5"}

Exclusion criteria

{"criterion_text":"- Subarachnoid hemorrhage deemed most likely of peri mesencephalic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)"}
{"criterion_text":"- Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)"}
{"criterion_text":"- Participation in another clinical therapeutic study"}
{"criterion_text":"- Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission"}
{"criterion_text":"- Patients with a known hereditary complement deficiency (including hereditary angioedema)"}
{"criterion_text":"- Patients with a history of sensibility to blood products or C1-inhibitor"}
{"criterion_text":"- Patients with a know history of thrombosis (when known at time of inclusion)"}
{"criterion_text":"- Pregnant women"}

Endpoints

Primary endpoints

{"endpoint_text":"- Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies","definition_or_measurement_approach":"Defined as either a new focal neurological impariment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies"}
{"endpoint_text":"- Number of participants with complications during hospitalization","definition_or_measurement_approach":""}

Secondary endpoints

{"endpoint_text":"- Cerebral infarction on brain CT at 14 days","definition_or_measurement_approach":"Assessment by brain CT at 14 days"}
{"endpoint_text":"- Mortality","definition_or_measurement_approach":""}
{"endpoint_text":"- Daily neurological condition measured bij GCS during the first 14 days","definition_or_measurement_approach":"Daily measurement using Glasgow Coma Scale during first 14 days"}
{"endpoint_text":"- Complement activity in serum and CSF","definition_or_measurement_approach":"Measurement of complement activity in serum and cerebrospinal fluid (assay-based)"}
{"endpoint_text":"- Coagulation cascade activation","definition_or_measurement_approach":""}
{"endpoint_text":"- ICU length of stay","definition_or_measurement_approach":"Measured as number of days in intensive care unit"}
{"endpoint_text":"- Ventilator days","definition_or_measurement_approach":"Measured as number of days on mechanical ventilation"}

Recruitment

Planned Sample Size: 128
Recruitment Window Months: 32
Consent Approach: Informed consent documents are present: 'L1_SIS and ICF patient', 'L1_SIS and ICF representative', and 'L1_SIS and ICF Follow-up' (documents listed). Consent is provided by adult participants (minimum age 18). A representative ICF indicates procedures for consent by a legal representative when the participant lacks capacity. The public record includes Dutch translations of study titles; specific ICF language versions are not specified in the available data.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 128

Netherlands

Earliest CTIS Part Ii Submission Date: 21-01-2025
Latest Decision Or Authorization Date: 09-03-2025
Processing Time Days: 47
Number Of Sites: 1
Number Of Participants: 128

Sites

Site Name: Haaglanden Medisch Centrum Stichting
Department Name: Neurosurgery
Contact Person Name: Daan de Groot
Contact Person Email: wetenschapsbureau@haaglandenmc.nl

Sponsor

Primary sponsor

Full Name: Haaglanden Medisch Centrum Stichting
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Netherlands

Third parties

{"country":"","full_name":"Takeda Pharmaceuticals","duties_or_roles":"Financial support","organisation_type":""}
{"country":"","full_name":"Sint Jacobusstichting Stichting Haaglanden Medisch Centrum","duties_or_roles":"Financial support","organisation_type":""}

Investigational products

Investigational Product Name: Cinryze 500 IU powder and solvent for solution for injection
Active Substance: C1 esterase inhibitor (human)
Modality: Peptide/protein/enzyme
Routes Of Administration: IV INFUSION
Route: IV INFUSION
Authorisation Status: Marketing authorisation: EU/1/11/688/001
Maximum Dose: 6000 IU

Investigational Product Name: Sodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion.
Active Substance: SODIUM CHLORIDE
Modality: Small molecule
Routes Of Administration: IV INFUSION
Route: IV INFUSION
Authorisation Status: Marketing authorisation: PA0736/003/001 (IE)
Maximum Dose: 6 mmol/kg

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