Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period
研究概览
简要总结
This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.
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
- •Written informed consent must be obtained before any assessment is performed.
- •Subject was enrolled in the QCC374X2201 study and completed per protocol
排除标准
- •Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e. selexipag) since the last study drug intake in the QCC374X2201 study.
- •Females who are pregnant, or who plan to become pregnant during the study, or who are breastfeeding
- •Any known factor or disease that may interfere with treatment compliance or study conduct (i.e. drug or alcohol dependence)
- •Subjects who withdrew consent from the study QCC374X2201
研究组 & 干预措施
QCC374
placebo patients from QCC374X2201 rolled into extension study will start at 0.03mg b.i.d. or 0.06mg b.i.d. and have the opportunity to up-titrate 0.12mg
-active patients will continue at the dose they finished on the QCC374X2201 study
干预措施: QCC374 (Drug)
结局指标
主要结局
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period
时间窗: Two years
Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported
次要结局
- Maximum Observed Plasma Concentration (Cmax)(16 weeks)
- Time to Reach the Maximum Plasma Concentration (Tmax)(16 Weeks)
- Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau)(16 Weeks)
- Change From Baseline in Six Minute Walk Distance (6MWD)(16 weeks)
- Change From Baseline in RV Tei Index at Week 16 (Day 112) Using Echocardiography(16 weeks)
- Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)(16 weeks)
- Change in Tricuspid Annular Peak Systolic Velocity (TA S') at Week 16 (Day 112) Using Echocardiography(Two Years)
- Change From Baseline in RV Fractional Area Change at Week 16 (Day 112) Using Echocardiography(16 weeks)