Active — Not RecruitingPhase 2

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

United States120 participantsStarted 2022-10-10

Plain-language summary

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

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: * Confirmed diagnosis of spontaneous, non-traumatic ICH. * 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment) * Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms * Age ≥ 18 years * Able to receive first dose of test article ≤ 24h after onset of ICH symptoms * NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization * Controlled blood pressure (systolic BP \< 180 mm Hg) at randomization. * Premorbid magnetic resonance spectroscopy (mRS) of 0-2 * Has adequate venous access * No planned surgical intervention except EVD * Written informed consent from the patient or legally authorized representative (LAR) Exclusion Criteria: * Unstable hematoma defined as \> 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms. * Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed). * Uncontrolled temp \>38.5˚C at enrollment. * Signs of intracranial infection or emergence of a systemic infection * Is pregnant or lactating * Signs of liver and kidney chronic disease (i.e. creatinine \>2, bilirubin \> 3, receiving dialysis) * Non-reversible bleeding diathesis * Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the pas…

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

Difference in the proportion of all cause-morality between arms

Timeframe: 7 days post-randomization

Trial details

NCT IDNCT05020535

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

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.