2024-517943-29-00招募中3 期
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)
Liquidia Technologies Inc.43 个研究点 分布在 10 个国家目标入组 121 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 121
- 试验地点
- 43
- 主要终点
- Change from Baseline to Week 16 in 6-minute walk distance (6MWD)
研究概览
简要总结
To evaluate the effect of inhaled L606 on the change in walk distance as measured by the six-minute walk test (6MWT) in WHO Group 3 participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Open-label Extension Period
- 盲法
- None
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
- •Participant is between 18 years to 80 years old
- •Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging
- •Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: a. Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5, and b. Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and c. Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg
- •FEV1/FVC (ratio) > 0.70
- •6-minute walk distance ≥ 150 meters
排除标准
- •PH in the updated WHO Classification Groups 1, 2, 4, or 5
- •Has evidence of clinically significant left-sided heart disease as defined by echocardiography
- •Participants with history of persistent/permanent or uncontrolled atrial fibrillation
- •Participants with severe obstructive sleep apnea
- •Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics
- •Initiation of pulmonary rehabilitation
- •Severe coronary heart disease or unstable angina or myocardial infarction within 180 days prior to Screening
研究组 & 干预措施
L606 Placebo Inhalation Suspension
Placebo
干预措施: L606 Placebo Inhalation Suspension (Drug)
Treprostinil Liposome, Treprostinil Liposome, Treprostinil Liposome, Treprostinil Liposome, Treprostinil Liposome, Treprostinil Liposome
Test
干预措施: Treprostinil Liposome (Drug)
结局指标
主要结局
Change from Baseline to Week 16 in 6-minute walk distance (6MWD)
Change from Baseline to Week 16 in 6-minute walk distance (6MWD)
次要结局
- Time to first occurrence of 1 of the following clinical worsening event (CWE) criterion are met: -Death (all causes) -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study, at 2 consecutive visits and at least 1 week apart
- Change from Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
- Change from Baseline to Week 16 in 6MWD
研究者
Liquidia Clin Dev and Ops
Scientific
Liquidia Technologies Inc.
研究点 (43)
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