An Open-label Study to Evaluate the Safety and Tolerability of LIQ861 in Participants With WHO Group 1 PAH Transitioning From Oral Selexipag to Inhaled Treprostinil
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
研究概览
简要总结
This study will look at safety and tolerability of LIQ861 (treprostinil) inhalation powder in adults with pulmonary arterial hypertension (PAH, WHO Group 1) who switch from selexipag, a medicine taken by mouth, to treprostinil, a medicine breathed into the lungs.
Everyone who takes part will receive LIQ861. On the first study day, participants will stop taking selexipag and begin taking LIQ861 four times a day using a small handheld dry powder inhaler. The dose may be increased over time based on how well it is tolerated. Participants will take LIQ861 for 16 weeks.
The study will also look at whether switching to LIQ861 affects walking distance, a blood marker of heart strain, and symptoms reported by participants.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 80 years of age
- •Documented findings on right heart catheterization consistent with a diagnosis of WHO Group 1 pulmonary arterial hypertension of one of the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue disease; or PAH associated with simple congenital systemic-to-pulmonary shunts repaired at least 1 year previously
- •Receiving selexipag at any dose between 200 and 1600 mcg twice daily for at least 90 days, and willing and able to transition from selexipag to LIQ861 due to unsatisfactory clinical response or tolerability issues
- •May be receiving up to 2 additional approved non-prostacyclin oral PAH therapies at a stable dose and regimen, planned to continue unchanged for the duration of the study
- •New York Heart Association Functional Class II or III
- •Able to demonstrate correct use of the dry powder inhaler
排除标准
- •Pulmonary hypertension in WHO Group 2, 3, 4, or 5, or a WHO Group 1 subtype not listed in the inclusion criteria
- •Clinically significant left-sided heart disease by echocardiography, including left ventricular ejection fraction ≤ 45%, left atrial volume index > 48 mL/m², or hemodynamically significant valvular disease
- •Symptomatic coronary artery disease within the previous 6 months
- •Prior atrial septostomy
研究组 & 干预措施
Selexipag to LIQ861 (treprostinil) inhalation powder
干预措施: LIQ861 (treprostinil) inhalation powder (Combination Product)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Day 1 through 30 days after the last dose of study drug (up to approximately 24 weeks)
次要结局
未报告次要终点