Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 471
- 试验地点
- 153
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in United Therapeutics Study TDE-PH-310
- •All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
- •Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.
排除标准
- •The subject was pregnant or lactating.
- •The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
- •The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
- •The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
研究组 & 干预措施
UT-15C
Open label access
干预措施: UT-15C (treprostinil diolamine) (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
次要结局
- Change in Borg Dyspnea Score From Baseline to Week 48(Baseline to Week 48)
- Change in 6-Minute Walk Distance From Baseline(Baseline to Week 48)
- Change From Baseline to Week 48 in WHO Functional Class(Baseline to Week 48)
- Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48(Baseline to Week 48)