A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Change in Pulmonary Artery Pressure (PAP)
研究概览
简要总结
Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.
详细描述
Data will be collected on acute and chronic hemodynamic response to inhaled dry powder treprostinil (LIQ861) via right-heart catheterization. Study subjects will contribute to the overall safety profile of LIQ861.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Inhaled dry powder treprostinil (LIQ861)
Full study population receives inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg or 100μg capsule strengths.
干预措施: Inhaled dry powder treprostinil (LIQ861) (Drug)
结局指标
主要结局
Change in Pulmonary Artery Pressure (PAP)
时间窗: 2 hours (120 minutes) post-dose on Day 1 and Week 16
Systolic, diastolic, and mean pressure measured in millimeters of mercury (mmHG)
Change in Pulmonary Vascular Resistance (PVR)
时间窗: 2 hours (120 minutes) post-dose on Day 1 and Week 16
Calculated in Wood units
Change in Cardiac Output (CO)
时间窗: 2 hours (120 minutes) post-dose on Day 1 and Week 16
Measured in liters per minute (L/min)
Change in Pulmonary Artery Oxygen Saturation (PAO2%)
时间窗: 2 hours (120 minutes) post-dose on Day 1 and Week 16
Measured as a percent oxyhemoglobin saturation
次要结局
- Number of participants with treatment emergent adverse events (AEs)(Baseline until the end of study, approximately 18 months (Mar-2021))