A Two-Part Pharmacodynamic Study to Compare VentaProst (Epoprostenol Solution for Inhalation Via Custom Drug Delivery System) Dosing to Conventionally Administered Aerosolized Epoprostenol Dosing in Cardiac Surgery Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
研究概览
简要总结
The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly obtained with VentaProst titration.
详细描述
Part I:
This part of the study is designed to demonstrate the dose equivalence between off-label aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters.
Part II:
This part of the study is designed to establish a dose response relationship of VentaProst to hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and Men 18 to 75 years of age
- •Provide written informed consent
- •Willing and able to comply with all aspects of the protocol
- •For patients in Part I:
- •Undergo cardiac surgery on CPB
- •Clinically require treatment with and receive aerosolized epoprostenol
- •Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol
- •For patients in Part II:
- •Undergo cardiac surgery with CPB
- •Have perioperative pulmonary hypertension
- •Clinically require treatment with inhaled epoprostenol
排除标准
- •Current smoker (i.e., within the last 30 days)
- •Emergency operative status
- •Upper and/or lower respiratory tract infection within four weeks of screening
- •Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
- •Renal or severe hepatic impairment
- •Thromboembolic disease treated with anticoagulant therapy
- •Bleeding disorders
- •Significant restrictive or obstructive lung disease
- •History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
- •History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
- •Recent history of stroke or transient ischemic attack
- •Significantly abnormal laboratory tests at Screening
- •Pregnant or breastfeeding
- •Treatment with an investigational drug, biologic, or device within 30 days
- •Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for entry into this trial
- •Any condition where aerosolized epoprostenol is contraindicated
- •Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
研究组 & 干预措施
VentaProst
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
In Part 1, subjects were treated with a commercial aerosolized epoprostenol and then removed from that treatment. VentaProst was started and titrated to a dose equivalence to maintain at least 90% of hemodynamic response seen with the commerical product.
In Part 2, subjects were treated with VentaProst only.
干预措施: VentaProst (Combination Product)
结局指标
主要结局
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
时间窗: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
The primary goal was to establish the dose of VentaProst necessary to achieve a PD response comparable to the standard of care. The first dose of VentaProst tested, 17 ng/kg/min, achieved the dose equivalency.
次要结局
- Optimal Dose Determination With VP Dose Escalation (Part II)(Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days))