A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).
研究概览
简要总结
This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years and above
- •Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins
- •Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
- •Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil
- •Women of childbearing potential must use a reliable method of contraception
- •Signed informed consent prior to initiation of any study mandated procedure
排除标准
- •Patients with respiratory and/or cardiovascular distress in need of emergency care
- •Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- •Current use of IV inotropic agents
- •Current use of any prostacyclin or prostacyclin analog other than Flolan®
- •Tachycardia with heart rate > 120 beats/min at rest
- •PAH related to any condition other than those specified in the inclusion criteria
- •Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
- •Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
- •History of myocardial infarction
- •History of left-sided heart disease, including any of the following:
- •hemodynamically significant aortic or mitral valve disease
- •restrictive or congestive cardiomyopathy
- •left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
- •unstable angina pectoris
- •life-threatening cardiac arrhythmias
- •Chronic bleeding disorders
- •Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
- •Women who are pregnant or breast-feeding
- •Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
- •Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months
研究组 & 干预措施
EFI/ACT-385781A
EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump
干预措施: EFI/ACT-385781A (Drug)
结局指标
主要结局
Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).
时间窗: Approximately 3 months
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
次要结局
未报告次要终点