A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 115
- 主要终点
- An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP
研究概览
简要总结
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.
详细描述
Catecholamine-resistant hypotension (CRH) is an often fatal condition resulting from an underlying cause such as septic shock, inflammation due to trauma, or severe drug reactions. When these conditions occur, most patients will respond to either volume expansion or vasopressor treatment. However, some patients will require excessive doses of vasopressors and will be deemed to be resistant.
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of patients with catecholamine-resistant hypotension (CRH).
This is a multi-site, randomized, double-blind, placebo-controlled study. Adult patients with CRH, who are hospitalized in an ICU setting, may be eligible to participate. Approximately 315 patients will be enrolled.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of > 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg.
- •Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study.
- •Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study.
- •Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator.
- •Patients must have clinical features of high-output shock by meeting one of the following criteria.
- •Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg.
- •Cardiac Index (CI) > 2.3 L/min/1.73 m
- •Patient must meet 5a or 5b to be eligible.
- •Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
排除标准
- •Patients who are < 18 years of age.
- •Any patient with burns covering > 20% of total body surface area (TBSA).
- •Patients with a Cardiovascular (CV) SOFA score ≤
- •Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
- •Patients on veno-arterial (VA) ECMO.
- •Patients who have been on ECMO for less than 12 hours.
- •Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥
- •Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated.
- •Patients with acute mesenteric ischemia or a history of mesenteric ischemic.
- •Patients with a history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm.
- •Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- •Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
- •Patients with an expected lifespan of < 12 hours.
- •Patients with active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells.
- •Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling.
- •Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm
- •Patients with a known allergy to mannitol.
- •Patients who are current participating in another interventional clinical trial.
- •Patients who are known to be pregnant at the time of Screening.
研究组 & 干预措施
LJPC-501 (angiotensin II)
Treatment arm
干预措施: LJPC-501 (Drug)
Placebo (0.9% sodium chloride solution)
Placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP
时间窗: Hour 3
Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
次要结局
未报告次要终点