Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: EFI/ACT-385781A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFI/ACT-385781A<br>EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump | Drug: EFI/ACT-385781A<br> <br> * Other names: Epoprostenol for injection (EFI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months | 
| Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months | 
| Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months | 
| Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months | 
| Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months | 
| Change in Mean Cardiac Index From Baseline to End of Treatment (EOT). | 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. | Approximately 3 months |