Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (NCT05020535) | Clinical Trial Compass
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 range18 Years
SexALL
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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 \>38.5ËšC 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…
What they're measuring
1
Difference in the proportion of all cause-morality between arms