NCT02042014已完成3 期
An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
研究概览
简要总结
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
详细描述
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.
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
- •patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.
- •Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.
排除标准
- •Patient has been permanently discontinued from QTI571 study treatment in the parent study.
- •Concomitant use of oral vitamin K antagonist medication.
研究组 & 干预措施
QTI571
Experimental
Participants will receive QTI571 during 3 years.
干预措施: QTI571 (Drug)
结局指标
主要结局
Serious Adverse Events
时间窗: Approximately 2.9 years
All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other OptionHypertension, PulmonaryNCT05179876Actelion280
终止
3 期
Iloprost Power Disc-15 in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT00723554Actelion63
已完成
4 期
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionHypertension, PulmonaryPulmonary Arterial HypertensionNCT01642407Pfizer's Upjohn has merged with Mylan to form Viatris Inc.6
已完成
3 期
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)NCT03904693Actelion187
终止
3 期
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilPulmonary Arterial HypertensionPulmonary HypertensionNCT00796666Pfizer131