NCT03623529Unknown2 期
A Randomised, Placebo-controlled, Double-Blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age With Catecholamine-Resistant Hypotension Associated With Distributive Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
研究概览
简要总结
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female paediatric patients with catecholamine-resistant hypotension associated with distributive shock.
- •Paediatric patients > 2 years (ie, > 24 months) to < 18 years of age at enrolment.
- •Patients requiring a sum norepinephrine-equivalent dose > 0.1 μg/kg/min to maintain age-appropriate target MAP for a minimum of 2 hours and a maximum of 48 hours prior to initiation of study drug.
- •Patients must have a clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
- •Patients are required to have central venous access, which is expected to remain present for the duration of study drug treatment.
- •Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 48 hours of study drug treatment.
- •Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and must be adequately volume resuscitated in the opinion of the Investigator, prior to starting study drug.
- •Parent(s) or legal guardian(s) is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.
排除标准
- •Patients who are ≤ 2 years (24 months) of age or ≥ 18 years of age at enrolment.
- •Patients with a standing Do Not Resuscitate order.
- •Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
- •Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
- •Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
- •Patients with a clinical suspicion of cardiogenic shock based on echocardiogram.
- •Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
- •Patients with acute mesenteric ischaemia or a history of mesenteric ischaemia.
- •Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
- •Patients with active bleeding AND haemoglobin < 7 g/dL.
- •Patients with an expected lifespan of < 12 hours or expected withdrawal of life support within 24 hours of Screening.
- •Patients with a known allergy to mannitol.
- •Patients who are currently participating in another clinical trial using an investigational drug not approved in that member country unless specifically approved by the Sponsor.
- •Patients of childbearing potential who are known to be pregnant at the time of Screening.
研究组 & 干预措施
Active Comparator: LJPC-501
Experimental
LJPC-501 Angiotensin II Solution for infusion
干预措施: LJPC-501 (angiotensin II) (Drug)
Placebo Comparator: Placebo
Placebo Comparator
0.9% sodium chloride solution
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
时间窗: Hour 3
次要结局
- Effect on total catecholamine doses administered based on treatment with LJPC-501(Baseline, Hour 24 and Hour 48)
- Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501(Hour 24 and Hour 48)
- Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501(Day 7)
- Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501(Baseline, Hour 24 and Hour 48)
- Effect on heart rate based on treatment with LJPC-501(Baseline to Hour 3, Hour 24, and Hour 48)
- Effect on mean arterial pressure (MAP) based on treatment with LJPC-501(Baseline, Hour 3, Hour 24, and Hour 48)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of LJPC-501 in Pediatric Patients With HypotensionCatecholamine-resistant Hypotension (CRH)Distributive ShockHigh Output ShockSepsisNCT03431077La Jolla Pharmaceutical Company2
已完成
1 期
Drug Interaction Study of Avanafil and Enalapril or AmlodipineErectile DysfunctionNCT01117038VIVUS LLC48
已完成
1 期
A Phase 1 Crossover Study of Blood Pressure and Heart Rate ResponseHealthy SubjectsNCT01577459Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18
已完成
1 期
Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult VolunteersHealthy VolunteersNCT02916901Chong Kun Dang Pharmaceutical32
已完成
3 期
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)HypertensionNCT00092209Organon and Co840