2023-505539-11-00招募中3 期
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Insmed Inc.
- 入组人数
- 23
- 试验地点
- 12
- 主要终点
- Frequency and severity of TEAEs during the study
研究概览
简要总结
To evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009 201, INS1009 202, and other lead in studies of TPIP in participants with PAH.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants who completed the end of treatment visit in Study INS1009 201, Study INS1009 202, or any other lead in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
- •Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009 201, Study INS1009 202, or any other lead in PAH TPIP in study.
- •Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009 201, INS1009 202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso®] or iloprost) and oral prostacyclin analogues (eg, TRE [Orenitram®]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
- •QTcF interval > 480 ms on resting ECG at screening, not including participants with right bundle branch block (RBBB) leading to a prolongation of the QRS.
- •Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
- •New onset of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
- •New evidence of thromboembolic disease as assessed by VQ scan, pulmonary angiography, or pulmonary CT scan.
- •Active and current symptomatic COVID-19 or previous severe disease and/or hospitalization due to COVID-19
- •Current use of cigarettes (as defined by CDC) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days
- •Participants who currently inhale marijuana (recreational or medical).
- •Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PAH TPIP study, which, in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
结局指标
主要结局
Frequency and severity of TEAEs during the study
Frequency and severity of TEAEs during the study
次要结局
- Change from pre-OLE baseline to Month 6, Month 12, Month 18, and Month 24 in 6MWD (absolute and relative), in the concentration of NT proBNP in blood, in the REVEAL Lite 2.0 score, in NYHA/WHO functional capacity class.
- Annualized rate of clinical worsening events defined as one of the following: - All cause death, or onset of TEAE with a fatal outcome occurring ≤ 14 days after study drug discontinuation. - Hospitalization for right heart failure (for > 48 hours), heart lung or lung transplant, or atrial septostomy
- Addition (or increase in dose) of specified PAH-specific medications. Combined occurrence of events including a 20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure. Annualized clinical worsening event rate defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
- Plasma concentration levels of TP and TRE
研究者
Fraz Ismat
Scientific
Insmed Inc.
研究点 (12)
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