A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy - Tranilast-MD

Matsumura Tsuyoshi0 sites20 target enrollmentNovember 12, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 12, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Matsumura Tsuyoshi

•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

•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