Clinical trial NCT05970224: 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
Official title: A Phase IIa, Randomized, Open-label, Proof-of-Concept Study to Evaluate Safety, Tolerability and Efficacy of Ir-CPI in Patients With Spontaneous Intracerebral Haemorrhage
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Ir-CPI
ICH
Secondary brain injury
Ixodes ricinus-Contact Phase Inhibitor
Neutrophil
Antithrombotic
Intracranial hemorrhage
Stroke
Brain
Inflammation
Neuroinflammation
Cerebrovascular disorders
Lead sponsor: Bioxodes S.A.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 360 days post-randomization
measure: Incidence of abnormalities in physical examination
timeFrame: 7 days post-randomization
measure: Change from baseline in HR interval
timeFrame: 7 days post-randomization
measure: Change from baseline in PR interval
timeFrame: 7 days post-randomization
measure: Change from baseline in QRS duration
timeFrame: 7 days post-randomization
measure: Change from baseline in QRS axis
timeFrame: 7 days post-randomization
measure: Change from baseline in QT interval
timeFrame: 7 days post-randomization
measure: Change from baseline in blood pressure
timeFrame: 7 days post-randomization
measure: Change from baseline in heart rate
timeFrame: 7 days post-randomization
measure: Change from baseline in body temperature
timeFrame: 7 days post-randomization
Secondary outcomes:
measure: Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes
timeFrame: 10 days post-randomization
measure: Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT)
timeFrame: 7 days post-randomization
measure: Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities
timeFrame: 7 days post-randomization
measure: Change from baseline in Ir-CPI plasma concentrations
timeFrame: 7 days post-randomization
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
state: East Flanders
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish Brabant
city: Mons
country: Belgium
facility: CHU Ambroise Paré
state: Hainaut
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West Flanders
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West Flanders
city: Oostende
country: Belgium
facility: AZ Damiaan
state: West Flanders
city: Brussels
country: Belgium
facility: HUB Erasme
city: Brussels
country: Belgium
facility: UCL St Luc
city: Brussels
country: Belgium
facility: UZ Brussel
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
Study officials:
References: