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

NCT05970224 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: Clin_IrCPI_2012022-500491-53-00
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (10)

• Number of Participants with Adverse Events

  360 days post-randomization

• Incidence of abnormalities in physical examination

  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.

  7 days post-randomization

• Change from baseline in HR interval

  Measured by standard 12-lead ECG

  7 days post-randomization

• Change from baseline in PR interval

  Measured by standard 12-lead ECG

  7 days post-randomization

• Change from baseline in QRS duration

  Measured by standard 12-lead ECG

  7 days post-randomization

• Change from baseline in QRS axis

  Measured by standard 12-lead ECG

  7 days post-randomization

• Change from baseline in QT interval

  Measured by standard 12-lead ECG. Two corrections of the QT interval will be investigated: Fridericia's correction (QTcF) and Bazett's correction (QTcB)

  7 days post-randomization

• Change from baseline in blood pressure

  Blood pressure (systolic and diastolic) is measured using an automatic device

  7 days post-randomization

• Change from baseline in heart rate

  Heart rate is measured using an automatic device

  7 days post-randomization

• Change from baseline in body temperature

  Measurement of tympanic temperature

  7 days post-randomization

Secondary Outcomes (4)

• Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes

  10 days post-randomization

• Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT)

  7 days post-randomization

• Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities

  7 days post-randomization

• Change from baseline in Ir-CPI plasma concentrations

  7 days post-randomization

Study Arms (2)

Ir-CPI

EXPERIMENTAL

Ir-CPI will be administered on top of standard of care

Drug: Ir-CPI

Standard care

NO INTERVENTION

Only standard of care

Interventions

Ir-CPI DRUG

Participants receive a single intravenous dose of Ir-CPI during 48 hours

Ir-CPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bioxodes S.A.: lead

Study Sites (10)

HUB Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

UCL St Luc

Brussels, Brussels Capital, Belgium

Location

UZ Brussel

Brussels, Brussels Capital, Belgium

Location

UZ Gent

Ghent, East Flanders, 9000, Belgium

Location

UZ Leuven

Leuven, Flemish Brabant, Belgium

Location

CHU Ambroise Paré

Mons, Hainaut, 7000, Belgium

Location

AZ Sint-Jan

Bruges, West Flanders, 8000, Belgium

Location

AZ Groeninge

Kortrijk, West Flanders, 8500, Belgium

Location

AZ Damiaan

Ostend, West Flanders, 8400, Belgium

Location

Clinique CHC MontLégia

Liège, Belgium

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Stroke; Inflammation; Neuroinflammatory Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: November 17, 2023
• Primary Completion: March 20, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (10)