JPRN-jRCTs031180038进行中（未招募）Unknown
A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy - Tranilast-MD
Matsumura Tsuyoshi0 个研究点目标入组 20 人开始时间: 2018年11月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 13age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) MD patients aged 13 or more
- •2) With high value in BNP (100 pg/mL or more)
- •3) 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.
- •4) To whom intrinsic administration of capsule, fine granules or dry syrup is possible, or who can be reliably administered tranilast by tube
- •5) Provided written consent by their free will / the representative
排除标准
- •1) Acute stage heart failure condition (using cardiotonic, diuretic, antiarrhythmic drug intravenously)
- •2) 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
- •3) With a lethal arrhythmia including ventricular premature contraction of more than four (short run)), excluding those with transplanted implantable defibrillators
- •4) 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.
- •5) 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 )
- •6) Marked white blood cell (WBC) decrease (less than 3000/mm^3), platelet (Plt) decrease (less than 80,000/mm^3)
- •7) Having a history of hypersensitivity to tranilast
- •8) Pregnant or possibly pregnant
- •9) For whom the principal investigator/sub-investigators judged not appropriate for participation in this study
研究者
相似试验
已完成
不适用
A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophyJPRN-UMIN000031965ational Hospital Organization Toneyama National Hospital20
进行中（未招募）
不适用
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial SeizuresEpilepsyPartial SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004335-39-Outside-EU/EEACB Japan Co. Ltd.70
已完成
不适用
A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneratiobone defectJPRN-UMIN000018192TOYOBO CO., LTD.60
招募中
不适用
The DeLIVER NZ Study will evaluate the safety of the Integrated Radio Frequency (iRF) Denervation System which is designed to improve blood pressure in patients with hypertnesion.Metabolic and Endocrine - DiabetesCardiovascular - HypertensionHypertensionType 2 Diabetes MellitusMetabolic and Endocrine - Other metabolic disordersMetabolic and Endocrine - Metabolic disordersACTRN12619001524189Metavention, Inc.30
进行中（未招募）
2 期
Multicenter, single-group, open-label study of T-cell-replete haploidentical stem cell transplantation for relapsed and refractory childhood acute leukemia with low dose anti-thymocyte immunoglobuliAcute leukemiaJPRN-jRCTs041190061Kobayashi Shogo38