Dataset from Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension

This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.

本研究纳入接受吸入用曲前列尼尔（inhaled treprostinil）治疗的肺动脉高压（pulmonary arterial hypertension, PAH）受试患者。研究实施期间，将对患者的吸入用曲前列尼尔治疗方案进行逐步减量并停用，同步以作用机制相似的口服治疗药物司来帕格（selexipag）完成替代治疗。本研究旨在达成以下三项目标：其一，探究由吸入用曲前列尼尔转换为司来帕格治疗的PAH患者的用药安全性与耐受性；其二，分析治疗转换前后，口服司来帕格对PAH病情严重程度及运动能力的影响；其三，对比患者服用口服司来帕格与吸入用曲前列尼尔的用药体验，获取相关新增临床信息。受试患者可留在本研究队列中，直至美国食品药品监督管理局（Food and Drug Administration, FDA）获批该药物的上市许可。