jRCTs031180038已完成不适用
A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy (Tranilast-MD)
未提供0 个研究点目标入组 20 人开始时间: 2018年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- The change in BNP
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 13age old over 至 No limit（—）
- 性别
- All
入选标准
- •MD patients aged 13 or more
- •With high value in BNP (100 pg/mL or more)
- •Those introduced with standard myocardium protective drugs (angiotensin converting enzyme inhibitor (ACEI)/angiotensin type II receptor blocker (ARB) and/or beta blocker) who meets both of the following:
- •taking maintenance doses at the time of consent;
- •whose dosage regimen and doses are fixed from 2 weeks before the start of administration until the start of administration.
- •To whom intrinsic administration of capsule, fine granules or dry syrup is possible, or who can be reliably administered tranilast by tube
- •Provided written consent by their free will / the representative
排除标准
- •Acute stage heart failure condition (using cardiotonic, diuretic, antiarrhythmic drug intravenously)
- •From 2 weeks before the start of administration to the start of administration Directions of digitalis, diuretic, aldosterone antagonist, cardiotonic agent, antiarrhythmic drug are not fixed
- •With a lethal arrhythmia including ventricular premature contraction of more than four (short run)), excluding those with transplanted implantable defibrillators
- •With serious renal dysfunction (estimated glomerular filtration ratio (eGFR) using cystatin C of less than 30 mL/min/1.73 m2)
- •Male: eGFR = (104 ^ Cystatin C-1.019^ 0.996age (years)) - 8
- •Female: eGFR = (104 ^ Cystatin C-1.019 ^ 0.996age (years) ^ 0.929) - 8
- •For those aged 18 or less, cyctain C of 2.5 mg/L or more is used.
- •With severe liver function disorder (T. Bil of 10 mg/dl or more, AST and ALT of 500 IU/L or more, ALP of 5 times or more of the normal upper limit, PT of 40% or less, bleeding tendency, hepatic failure symptoms (fulminant hepatitis), cirrhosis of the liver, liver tumor, jaundice prolonged for more than 6 months) (equivalent to grade 3 in "Classification criteria for severity of adverse drug reactions" )
- •Marked white blood cell (WBC) decrease (less than 3000/mm^3), platelet (Plt) decrease (less than 80,000/mm^3)
- •Having a history of hypersensitivity to tranilast
- •Pregnant or possibly pregnant
- •For whom the principal investigator/sub-investigators judged not appropriate for participation in this study
结局指标
主要结局
The change in BNP
时间窗: 24 weeks
The change in BNP before the start of administration (using the average of values in the pre-treatment observation period and at the start of administration) to 24 weeks (using the average of values at 20 weeks, 24 weeks and 28 weeks)
次要结局
- Cardiac events
研究者
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