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Trial record 1 of 2 for:    ir-cpi
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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 (BIRCH)

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ClinicalTrials.gov Identifier: NCT05970224
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Bioxodes S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Ir-CPI Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ir-CPI
Ir-CPI will be administered on top of standard of care
 Drug: Ir-CPI
Participants receive a single intravenous dose of Ir-CPI during 48 hours
No Intervention: Standard care
Only standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 360 days post-randomization ]
  2. Incidence of abnormalities in physical examination [ Time Frame: 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.

  3. Change from baseline in HR interval [ Time Frame: 7 days post-randomization ]
    Measured by standard 12-lead ECG

  4. Change from baseline in PR interval [ Time Frame: 7 days post-randomization ]
    Measured by standard 12-lead ECG

  5. Change from baseline in QRS duration [ Time Frame: 7 days post-randomization ]
    Measured by standard 12-lead ECG

  6. Change from baseline in QRS axis [ Time Frame: 7 days post-randomization ]
    Measured by standard 12-lead ECG

  7. Change from baseline in QT interval [ Time Frame: 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)

  8. Change from baseline in blood pressure [ Time Frame: 7 days post-randomization ]
    Blood pressure (systolic and diastolic) is measured using an automatic device

  9. Change from baseline in heart rate [ Time Frame: 7 days post-randomization ]
    Heart rate is measured using an automatic device

  10. Change from baseline in body temperature [ Time Frame: 7 days post-randomization ]
    Measurement of tympanic temperature


Secondary Outcome Measures :
  1. Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes [ Time Frame: 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.

  2. Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT) [ Time Frame: 7 days post-randomization ]
    Activated partial thromboplastin time (aPTT) will be used as a pharmacodynamic marker

  3. Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities [ Time Frame: 7 days post-randomization ]
    The inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities will be assessed to support the aPTT dynamics

  4. Change from baseline in Ir-CPI plasma concentrations [ Time Frame: 7 days post-randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Planned 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05970224


Contacts
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Contact: Charlotte Corbisier +32 (0)472 21 01 20 charlotte.corbisier@bioxodes.com

Locations
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Belgium
UZ Gent Recruiting
Gent, East Flanders, Belgium, 9000
Contact: Wendy Stoop         
UZ Leuven Recruiting
Leuven, Flemish Brabant, Belgium
Contact: Annemie Devroye         
CHU Ambroise Paré Recruiting
Mons, Hainaut, Belgium, 7000
Contact: Virginie Vanderhaegen         
AZ Sint-Jan Recruiting
Brugge, West Flanders, Belgium, 8000
Contact: Heleen Couckuyt         
AZ Groeninge Recruiting
Kortrijk, West Flanders, Belgium, 8500
Contact: Isabelle Vanpantghem         
AZ Damiaan Recruiting
Oostende, West Flanders, Belgium, 8400
Contact: Louise Vandenbroucke         
HUB Erasme Recruiting
Brussels, Belgium, 1070
Contact: Patrick Lamotte         
UCL St Luc Recruiting
Brussels, Belgium
Contact: Ayhan Findik         
UZ Brussel Recruiting
Brussels, Belgium
Contact: Karen Vandaele         
Clinique CHC MontLégia Recruiting
Liège, Belgium
Contact: Karima Bouaassam         
Sponsors and Collaborators
Bioxodes S.A.
More Information
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Responsible Party: Bioxodes S.A.
ClinicalTrials.gov Identifier: NCT05970224    
Other Study ID Numbers: Clin_IrCPI_201
2022-500491-53-00 ( Registry Identifier: CTIS )
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bioxodes S.A.:
Ir-CPI
ICH
Secondary brain injury
Ixodes ricinus-Contact Phase Inhibitor
Neutrophil
Antithrombotic
 Intracranial hemorrhage
Stroke
Brain
Inflammation
Neuroinflammation
Cerebrovascular disorders
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases