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New drug aims to curb brain injury after stroke

NCT ID NCT05970224

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Nov 2023

Finished

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

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

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.

cerebrovascular disorder Inflammation intracerebral hemorrhage Intracranial Hemorrhages Neuroinflammatory Diseases stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AZ Damiaan

    Ostend, West Flanders, 8400, Belgium

  • AZ Sint-Jan

    Bruges, West Flanders, 8000, Belgium

  • CHU Ambroise Paré

    Mons, Hainaut, 7000, Belgium

  • Clinique CHC MontLégia

    Liège, Belgium

  • UCL St Luc

    Brussels, Belgium

  • UZ Brussel

    Brussels, Belgium

  • UZ Gent

    Ghent, East Flanders, 9000, Belgium

  • UZ Leuven

    Leuven, Flemish Brabant, Belgium

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