NCT02388529撤回1 期
A Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Due to Reduced Left Ventricular Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This study is a single-center, randomized, double-blind, placebo-controlled study in patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •LVEF ≤45% by 2-D echocardiogram.
- •Diagnosis of New York Heart Association Class II or III HF for a minimum of 6 months prior to the Screening Visit.
- •HF is considered to be stable, in the judgment of the Principal Investigator and no hospitalization related to HF has occurred within the 1 month prior to the Screening Visit.
- •Treatment with appropriate pharmacologic therapy for HF including, but not limited to, angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB), and an evidence-based beta blocker for the treatment of HF
- •Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit.
- •Written informed consent obtained that strictly adheres to the written guidelines from the local Ethical Committee (EC).
排除标准
- •Unstable angina pectoris within 1 month before initiation of screening procedures. Unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (e.g., nitroglycerin).
- •Coronary or peripheral artery revascularization procedure within 2 months prior to the Screening Visit.
- •An acute myocardial infarction within 3 months prior to the Screening Visit.
- •Supine resting heart rate ≥ 100 beats per minute after 5 minutes rest.
- •Uncontrolled hypertension defined as a systolic blood pressure (BP) >180 mm Hg or a diastolic BP >110 mm Hg on at least 2 consecutive readings.
- •Requirement for valve or other cardiac surgery (e.g., pericardectomy).
- •Cardiac surgery or valvuloplasty within 2 month prior to the Screening Visit.
- •General surgery within 1 month prior to the Screening Visit.
- •Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic left ventricular aneurysm.
- •Cerebrovascular accident or transient ischemic attack within 3 months prior to the Screening Visit.
- •Liver enzyme (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) elevation >3x the upper limit of normal (ULN).
- •Estimated glomerular filtration rate (eGFR) <30 mL/min, using the Modification of Diet in Renal Disease (MDRD) Study equation.
- •Known active drug or alcohol abuse.
- •Active infection requiring systemic treatment or surgical intervention.
- •Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
- •Female patients who are pregnant or breastfeeding.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Intermediate dose
Experimental
干预措施: MTP-131 (Drug)
Low dose
Experimental
干预措施: MTP-131 (Drug)
High dose
Experimental
干预措施: MTP-131 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Assessed up to Day 33
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
时间窗: Assessed up to Day 12
次要结局
- Changes in echocardiographic LV end-systolic volume (LVESV)(Assessed up to Day 33)
研究者
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