A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage
- Registration Number
- NCT05970224
- Lead Sponsor
- Bioxodes S.A.
- Brief Summary
The purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 23
- Male or female patients aged ≥ 18 years.
- Written informed consent obtained before any study assessment. If the patient is not able to give the informed consent personally, consent by a legal representative as defined by local law and regulation is acceptable.
- First-ever, spontaneous, supratentorial intracerebral haemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 5 mL and ≤ 60 mL determined by non-contrast CT scan.
- Patients with Glasgow Coma Scale (GCS) best motor score no less than 5.
- Modified Rankin Scale (mRS) score 0-2 prior to ICH symptom onset.
- History of personal or familial bleeding disorders; including prolonged or unusual bleeding.
- Known deficiency in factor XII (FXII) or haemophilia type A (FVII) or type B (FIX) or type C (FXI).
- Infratentorial (midbrain, pons, medulla, or cerebellum) ICH.
- Secondary ICH due to aneurysm, brain tumour, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic brain injury (TBI), or disseminated intravascular coagulation (DIC).
- Planned neurosurgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation.
- Anticoagulation reversal treatment.
- Patients with intraventricular haemorrhage (IVH) having a Graeb score of >3 on initial presentation. Patients must not have blood in the 4th ventricle and may only have blood in the 3rd ventricle in the absence of ventricular expansion. Trace or mild haemorrhage in either or both lateral ventricles is permitted. Patients with hydrocephalus determined radiologically on initial presentation are excluded regardless of Graeb score.
- Use of immunosuppressive or immune-modulating therapy at admission (e.g., steroids, methotrexate, monoclonal antibodies, etc).
- Patients with active systemic bacterial, viral or fungal infections.
- Women of childbearing potential.
- Have a body weight > 120 kg at screening.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ir-CPI Ir-CPI Ir-CPI will be administered on top of standard of care
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events 360 days post-randomization Incidence of abnormalities in physical examination 7 days post-randomization A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, dermatological, neurological (including basic neurological testing for isocoria, light reflexes, gait and balance), musculoskeletal and lymphatic systems, in addition to head, eyes, ears, nose, throat, and neck.
Change from baseline in HR interval 7 days post-randomization Measured by standard 12-lead ECG
Change from baseline in PR interval 7 days post-randomization Measured by standard 12-lead ECG
Change from baseline in QRS duration 7 days post-randomization Measured by standard 12-lead ECG
Change from baseline in QRS axis 7 days post-randomization Measured by standard 12-lead ECG
Change from baseline in QT interval 7 days post-randomization Measured by standard 12-lead ECG. Two corrections of the QT interval will be investigated: Fridericia's correction (QTcF) and Bazett's correction (QTcB)
Change from baseline in blood pressure 7 days post-randomization Blood pressure (systolic and diastolic) is measured using an automatic device
Change from baseline in heart rate 7 days post-randomization Heart rate is measured using an automatic device
Change from baseline in body temperature 7 days post-randomization Measurement of tympanic temperature
- Secondary Outcome Measures
Name Time Method Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes 10 days post-randomization CT scans will be acquired by volumetric CT acquisition with reconstructions in 3 planes, in order to assess hematoma volume and perihematomal volume. Assessment of hematoma expansion will be performed by comparing follow-up CT scans with baseline CT.
Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT) 7 days post-randomization Activated partial thromboplastin time (aPTT) will be used as a pharmacodynamic marker
Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities 7 days post-randomization The inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities will be assessed to support the aPTT dynamics
Change from baseline in Ir-CPI plasma concentrations 7 days post-randomization
Trial Locations
- Locations (10)
UZ Gent
🇧🇪Gent, East Flanders, Belgium
AZ Sint-Jan
🇧🇪Brugge, West Flanders, Belgium
AZ Groeninge
🇧🇪Kortrijk, West Flanders, Belgium
UCL St Luc
🇧🇪Brussels, Belgium
UZ Brussel
🇧🇪Brussels, Belgium
Clinique CHC MontLégia
🇧🇪Liège, Belgium
UZ Leuven
🇧🇪Leuven, Flemish Brabant, Belgium
CHU Ambroise Paré
🇧🇪Mons, Hainaut, Belgium
AZ Damiaan
🇧🇪Oostende, West Flanders, Belgium
HUB Erasme
🇧🇪Brussels, Belgium