Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Difference in the proportion of all cause-morality between arms
研究概览
简要总结
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).
详细描述
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).
This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.
MW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, study staff, analytic staff (to patient identifiers), sponsor staff (only to treatment allocation, unblinded to enable handling and review of data and drug accountability prior to database lock)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Experimental
MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
干预措施: MW189 (Drug)
Control
Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
干预措施: Saline (Other)
结局指标
主要结局
Difference in the proportion of all cause-morality between arms
时间窗: 7 days post-randomization
Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.
次要结局
未报告次要终点