EUCTR2016-001411-20-DE进行中（未招募）1 期
ong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
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
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
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
- •Other protocol-defined exclusion criteria may apply.
研究者
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