Active — Not RecruitingPhase 2

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

Belgium23 participantsStarted 2023-11-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events

Timeframe: 360 days post-randomization

Incidence of abnormalities in physical examination

Timeframe: 7 days post-randomization

Change from baseline in HR interval

Timeframe: 7 days post-randomization

Change from baseline in PR interval

Timeframe: 7 days post-randomization

Change from baseline in QRS duration

Timeframe: 7 days post-randomization

Change from baseline in QRS axis

Timeframe: 7 days post-randomization

Change from baseline in QT interval

Timeframe: 7 days post-randomization

Trial details

NCT IDNCT05970224

SponsorBioxodes S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-20

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adverse Events

Timeframe: 360 days post-randomization

Incidence of abnormalities in physical examination

Timeframe: 7 days post-randomization

Change from baseline in HR interval

Timeframe: 7 days post-randomization

Change from baseline in PR interval

Timeframe: 7 days post-randomization

Change from baseline in QRS duration

Timeframe: 7 days post-randomization

Change from baseline in QRS axis

Timeframe: 7 days post-randomization

Change from baseline in QT interval

Timeframe: 7 days post-randomization