NCT01131637终止3 期
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Zensun Sci. & Tech. Co., Ltd.43 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 331
- 试验地点
- 43
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
详细描述
The mortality of chronic heart failure patients remains high, in spite of recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age between 18 and 80, both sex.
- •Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- •NYNA functional class III~Ⅳ.
- •Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
- •Capable of signing the informed consent form.
排除标准
- •Patients with acute pulmonary edema or acute hemodynamic disorder.
- •Patients with right heart failure caused by pulmonary disease.
- •Patients diagnosed with pericardial effusion or pleural effusion.
- •Patients with myocardial infarction during the preceding 3 months.
- •Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- •Unstable angina pectoris.
- •Cardiac surgery or cerebrovascular accident within recent six months.
- •Preparing for heart transplantation.
- •Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- •Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
- •Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- •Systolic blood pressure <90mmHg or >160mmHg.
- •Pregnant or plan to pregnant.
- •Patients who participated in any clinical trial in the recent three months.
- •Subject with a life expectancy less than 3 months as assessed by the investigator.
- •Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
- •History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- •Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- •Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
研究组 & 干预措施
rhNRG-1
Experimental
recombinant human neuregulin-1
干预措施: rhNRG-1 (Drug)
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
all cause mortality
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (43)
Loading locations...
相似试验
终止
3 期
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) PatientsChronic Heart FailureNCT01541202Zensun Sci. & Tech. Co., Ltd.679
招募中
3 期
Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.Chronic Heart FailureNCT03388593Zensun Sci. & Tech. Co., Ltd.1,600
已完成
1 期
Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid TumourSolid TumorsNCT00878111AGC Biologics S.p.A.48
已完成
2 期
An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry EyeDry EyeNCT03019627Dompé Farmaceutici S.p.A150
已完成
3 期
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With PemetrexedMalignant Pleural MesotheliomaNCT01098266AGC Biologics S.p.A.400