Clinical trial • Phase IV • Neurology

C1 ESTERASE INHIBITOR (HUMAN) for Traumatic brain injury

Phase IV trial of C1 ESTERASE INHIBITOR (HUMAN) for Traumatic brain injury.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Traumatic brain injury
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
12-09-2024
First CTIS Authorization Date
08-10-2024

Trial design

Saline Solution Basi 9 mg/ml solution for infusion (sodium chloride) - intravenous; dose/schedule not specified-controlled Phase IV trial across 3 sites in Netherlands.

Comparator
Saline Solution Basi 9 mg/ml solution for infusion (sodium chloride) - intravenous; dose/schedule not specified
Target Sample Size
106

Eligibility

Recruits 106 isVulnerablePopulationSelected = true. Participants are adults with traumatic brain injury. Subject information and informed consent forms available: 'L1_SIS and ICF adults' and 'L1_SIS and ICF follow-up'. No specific mention of assent or proxy consent in the provided data..

Vulnerable Population
isVulnerablePopulationSelected = true. Participants are adults with traumatic brain injury. Subject information and informed consent forms available: 'L1_SIS and ICF adults' and 'L1_SIS and ICF follow-up'. No specific mention of assent or proxy consent in the provided data.

Inclusion criteria

  • {"criterion_text":"- Traumatic Brain Injury\n- Age > 18 years\n- GCS < 13\n- ICP monitor"}

Exclusion criteria

  • {"criterion_text":"- < 18 years"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Therapy Intensity Level Scale","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Serious Adverse Events (SAE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Glasgow Outcome Scale Extended","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
106
Recruitment Window Months
70
Consent Approach
Informed consent forms available: 'L1_SIS and ICF adults' and 'L1_SIS and ICF follow-up'. Participants are adults (>18) so consent provided by the participant. No details on assent, proxy consent procedure, or languages available were provided in the supplied data.

Geography

Total Number Of Sites
3
Total Number Of Participants
106

Netherlands

Earliest CTIS Part Ii Submission Date
03-10-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
477
Number Of Sites
3
Number Of Participants
106

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Intensive Care
Contact Person Name
Mathieu van der Jagt
Contact Person Email
m.vanderjagt@erasmusmc.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Neurosurgery
Contact Person Name
Wouter Moojen
Contact Person Email
w.moojen@haaglandenmc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Neurosurgery
Contact Person Name
Thomas van Essen
Contact Person Email
t.a.van_essen@lumc.nl

Sponsor

Primary sponsor

Full Name
Leids Universitair Medisch Centrum (LUMC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

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
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation (EU/1/11/688/001)
Maximum Dose
6000 IU
Investigational Product Name
Saline Solution Basi 9 mg/ml solution for infusion
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number: 5211800)

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