Intracerebral HemorrhagePhase 2BIRCHNCT05970224
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
A Phase 2 study testing Ir-CPI in people with Intracerebral Hemorrhage, run by Bioxodes S.A. at 8 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Ir-CPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesBelgium
- Study dates
- 17 Nov 2023to 22 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
AZ Sint-Jan
Bruges, West Flanders, 8000
UCL St Luc
Brussels
UZ Brussel
Brussels
UZ Gent
Ghent, East Flanders, 9000
UZ Leuven
Leuven, Flemish Brabant
Clinique CHC MontLégia
Liège
CHU Ambroise Paré
Mons, Hainaut, 7000
AZ Damiaan
Ostend, West Flanders, 8400
About this study
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
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
- Being tested
- Ir-CPI
- Keywords
- Ir-CPI, ICH, Secondary brain injury, Ixodes ricinus-Contact Phase Inhibitor, Neutrophil, Antithrombotic, Intracranial hemorrhage, Stroke, Brain, Inflammation, Neuroinflammation, Cerebrovascular disorders
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages, Stroke, Inflammation, Neuroinflammatory Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ir-CPIDrug
Participants receive a single intravenous dose of Ir-CPI during 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Ir-CPI | Experimental | Ir-CPI will be administered on top of standard of care Receives: Drug: Ir-CPI |
| Standard care | No intervention | Only standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: 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.
Measured: 7 days post-randomization
Change from baseline in HR interval
Measured by standard 12-lead ECG
Measured: 7 days post-randomization
Change from baseline in PR interval
Measured by standard 12-lead ECG
Measured: 7 days post-randomization
Change from baseline in QRS duration
Measured by standard 12-lead ECG
Measured: 7 days post-randomization
Change from baseline in QRS axis
Measured by standard 12-lead ECG
Measured: 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)
Measured: 7 days post-randomization
Change from baseline in blood pressure
Blood pressure (systolic and diastolic) is measured using an automatic device
Measured: 7 days post-randomization
Change from baseline in heart rate
Heart rate is measured using an automatic device
Measured: 7 days post-randomization
Change from baseline in body temperature
Measurement of tympanic temperature
Measured: 7 days post-randomization
Secondary outcomes (4)
Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes
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.
Measured: 10 days post-randomization
Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT)
Activated partial thromboplastin time (aPTT) will be used as a pharmacodynamic marker
Measured: 7 days post-randomization
Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities
The inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities will be assessed to support the aPTT dynamics
Measured: 7 days post-randomization
Change from baseline in Ir-CPI plasma concentrations
Measured: 7 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Nov 2023
- Primary completion20 Mar 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioxodes S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970224
- Sponsor's protocol ID
- Clin_IrCPI_201
- Other IDs
- 2022-500491-53-00
- Acronym
- BIRCH
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970224
- Acronym / sponsor ID
- BIRCH / Clin_IrCPI_201
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Ir-CPI, ICH, Secondary brain injury, Ixodes ricinus-Contact Phase Inhibitor, Neutrophil, Antithrombotic, Intracranial hemorrhage, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bioxodes S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ir-CPI | Experimental | Drug: Ir-CPIIr-CPI will be administered on top of standard of care |
| Standard care | No intervention | –Only standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ir-CPIParticipants receive a single intravenous dose of Ir-CPI during 48 hours | Drug | Ir-CPI |
Primary outcome
Number of Participants with Adverse Events
Time frame: 360 days post-randomization
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.
Change from baseline in HR interval
Time frame: 7 days post-randomization
Measured by standard 12-lead ECG
Change from baseline in PR interval
Time frame: 7 days post-randomization
Measured by standard 12-lead ECG
Change from baseline in QRS duration
Time frame: 7 days post-randomization
Measured by standard 12-lead ECG
Change from baseline in QRS axis
Time frame: 7 days post-randomization
Measured by standard 12-lead ECG
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)
Change from baseline in blood pressure
Time frame: 7 days post-randomization
Blood pressure (systolic and diastolic) is measured using an automatic device
Change from baseline in heart rate
Time frame: 7 days post-randomization
Heart rate is measured using an automatic device
Change from baseline in body temperature
Time frame: 7 days post-randomization
Measurement of tympanic temperature
4 secondary outcomes
Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes
Time frame: 10 days post-randomization
Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT)
Time frame: 7 days post-randomization
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
Change from baseline in Ir-CPI plasma concentrations
Time frame: 7 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ir-CPI in people with Intracerebral Hemorrhage, run by Bioxodes S.A. at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 360 days post-randomization). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.