New drug aims to curb brain injury after stroke
NCT ID NCT05970224
First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This study tests a drug called Ir-CPI in 23 people who have had a bleeding stroke (intracerebral hemorrhage). The drug is given once through a vein over 48 hours, alongside standard care. The goal is to see if it is safe and can reduce swelling and further brain damage around the bleed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ir-CPI (a drug given as a single intravenous dose over 48 hours)
- What this could lead to
- If it works, this could point toward a treatment that limits brain damage after a hemorrhagic stroke.
- What could go wrong
- This is a very small, early-phase study (23 people) testing safety first. The drug may not reduce brain injury or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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23 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
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Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Damiaan
Ostend, West Flanders, 8400, Belgium
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AZ Sint-Jan
Bruges, West Flanders, 8000, Belgium
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CHU Ambroise Paré
Mons, Hainaut, 7000, Belgium
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Clinique CHC MontLégia
Liège, Belgium
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UCL St Luc
Brussels, Belgium
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UZ Brussel
Brussels, Belgium
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UZ Gent
Ghent, East Flanders, 9000, Belgium
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UZ Leuven
Leuven, Flemish Brabant, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Portable MRI could speed up stroke treatment
- Can a herbal formula match traditional medicine for brain bleeds?
- Can a blood marker tell fever from infection in stroke?
- Can blood markers predict brain injury outcomes?
- Can an ancient herbal pill improve outcomes after a bleeding stroke?