2024-514946-35-00招募中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
Regeneron Pharmaceuticals Inc.11 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年2月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 11
- 主要终点
- Cumulative vasopressor dose.
研究概览
简要总结
To evaluate the effect of REGN7544 on vasopressor requirements in participants with sepsis-induced hypotension.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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.
- •Other protocol defined inclusion criteria apply.
排除标准
- •Unable to obtain informed consent by participant or Legally Authorized Representative (LAR).
- •Other protocol-defined exclusion criteria apply.
- •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.
结局指标
主要结局
Cumulative vasopressor dose.
Cumulative vasopressor dose.
次要结局
- Magnitude of ADA to REGN7544.
- Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs).
- Time-weighted average mean arterial pressure (MAP).
- Change in MAP.
- Proportion of surviving participants free of vasopressor(s).
- Cumulative net fluid balance.
- Cumulative urine output.
- Cumulative fluid intake.
- Concentrations of REGN7544 in serum.
- Incidence of anti-drug antibodies (ADA) to REGN7544.
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (11)
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