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

ational Hospital Organization Toneyama National Hospital0 sites20 target enrollmentMarch 30, 2018

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: ational Hospital Organization Toneyama National Hospital
Enrollment: 20
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2018

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ational Hospital Organization Toneyama National Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•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