Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 in 12 Weeks
研究概览
简要总结
The main objective of this study is to evaluate the safety and tolerability of 12-week oral CXA-10 therapy in subjects with pulmonary arterial hypertension, with additional evaluation on the clinical efficacy of oral CXA-10 on changes in hemodynamics, exercise capacity, cardiovascular function and patient reported outcomes.
详细描述
This is a single-center, one-arm, open-label proof of concept safety study and a phase 2a proof of efficacy pre- and post-assessment study of oral CXA-10 for the treatment of pulmonary arterial hypertension.
The investigators hypothesize that administration of CXA-10 for 12 weeks will improves exercise capacity, cardiovascular function and health related quality of life in pulmonary arterial hypertension patients with limited toxicity.
Subjects who meet the inclusion criteria and none of the exclusion criteria will be scheduled within 4 weeks of screening to receive oral CXA-10 at the dose of 300 mg once daily followed by 12 weeks of open-label CXA-10 treatment and then a 4-week safety follow-up. Additional follow-up assessments by telephone will occur in between each outpatient clinic visit.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CXA-10
Oral CXA-10 300 mg once daily for 12 weeks
干预措施: CXA-10 (Drug)
结局指标
主要结局
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 in 12 Weeks
时间窗: Baseline to 12 Weeks
Numbers of treatment-related adverse events is assessed by CTCAE v4.0
次要结局
- Change From Baseline in Levels of Serum N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at 12 Weeks(at Baseline and 12 Weeks)
- Change From Baseline in Mean Pulmonary Artery Pressure is Measured at Baseline and 12 Weeks by Right Heart Catheterization(Baseline and 12 Weeks)
- Change From Baseline in Functional Status of Patients as Assessed by New York Heart Association Functional Class(at Baseline and 12 Weeks)
- Change From Baseline in Daily Physical Activity as Measured by a Accelerometer(Baseline and 12 Weeks)
- Change From Baseline in Pulmonary Vascular Resistance is Measured at Baseline and 12 Weeks by Right Heart Catheterization(Baseline and 12 Weeks)
- Change From Baseline in RV Function as Measured by Tricuspid Annular Plane Systolic Excursion (TAPSE) as Assessed by Echocardiograms at 12 Weeks(at baseline and 12 weeks)
- Changes From Baseline in Functional Exercise Capacity by Assessing 6 Minute Walk Distance Test(at baseline and 12 weeks)
研究者
Marc A. Simon
Associate Professor of Medicine
University of Pittsburgh