NCT07436689Enrolling By Invitation3 期
A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 800
- 试验地点
- 9
- 主要终点
- The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
研究概览
简要总结
The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed a TNX-103 parent study
- •Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103
- •Requirements related to childbearing potential, contraception, and egg/sperm donation
排除标准
- •Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being
- •Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
- •Pregnancy or breastfeeding in females
研究组 & 干预措施
TNX-103
Experimental
Open-label oral levosimendan 1-3mg
干预措施: TNX-103 (Drug)
结局指标
主要结局
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
时间窗: From enrollment through study completion (up to 3 years)
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.
次要结局
未报告次要终点
研究者
研究点 (9)
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