Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Running, not enrolling · Phase 2

Conditions studied: Intracerebral Hemorrhage

In brief

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).

Key facts

Study ID

NCT05020535

Run by

Johns Hopkins University

People needed

120

Starts

2022-10-10

Expected to finish

2027-10-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 past 7 days.
• Anticipated withdrawal of life-sustaining therapies within the first week after admission.
• In the opinion of the investigator, patient has any contraindication to the planned study assessments.
• In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.
• Concomitant enrollment in another acute interventional study

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Cleveland Clinic Florida — Stuart, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• New York University Grossman School of Medicine — Brooklyn, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Texas Houston — Houston, Texas, United States
• University of Texas San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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