NCT06608901已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients With Sepsis-Induced Hypotension
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 39
- 主要终点
- Cumulative vasopressor dose
研究概览
简要总结
This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis.
The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during the stay in the hospital.
The study is looking at several other research questions, including:
- How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
- •Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol
排除标准
- •Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)
- •Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
- •Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
- •Ejection fraction <20% in the most recent known echocardiogram
- •Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
- •History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months
- •Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
- •Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration
- •Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
- •NOTE: Other Protocol-Defined Inclusion-Exclusion Criteria Apply
研究组 & 干预措施
Placebo (PB)
Placebo Comparator
干预措施: PB (Drug)
REGN7544
Experimental
干预措施: REGN7544 (Drug)
结局指标
主要结局
Cumulative vasopressor dose
时间窗: Through 72 Hours
次要结局
- Proportion of surviving participants free of vasopressor(s)(At 24, 48 and 72 Hours)
- Cumulative net fluid balance(Through 72 Hours)
- Cumulative fluid intake(Through 72 Hours)
- Concentrations of REGN7544 in serum(Through 90 Days)
- Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)(Through 90 Days)
- Time-weighted average Mean Arterial Pressure (MAP)(Baseline Over 4 Hours)
- Change in MAP(Baseline, At 4 Hours)
- Proportion of surviving participants free of vasopressor(s)(At 24, 48 and 72 Hours)
- Cumulative net fluid balance(Through 72 Hours)
- Cumulative urine output(Through 72 Hours)
- Cumulative fluid intake(Through 72 Hours)
- Concentrations of REGN7544 in serum(Through 90 Days)
- Incidence of Anti-Drug Antibodies (ADA) to REGN7544(Through 90 Days)
- Magnitude of ADA to REGN7544(Through 90 Days)
研究者
研究点 (39)
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