Effects of glavonoid for transthyretin amyloidosis

Tahara Nobuhiro0 个研究点目标入组 40 人开始时间: 2023年11月20日最近更新: 2024年1月22日

试验速览

暂无简介。

•1) Subjects with pathologically confirmed deposition of transthyretin amyloid protein.
•2) Age of 18 years or older at screening and written informed consent to participate in this study.
•3) Subjects who do not meet the following indication criteria for tafamidis (*).
•* Indication criteria for tafamidis.
•1. Wild-type transthyretin-derived cardiac amyloidosis
•a. Medical history of hospitalization for heart failure or a heart failure condition requiring treatment with a diuretic for improvement.
•b. Presence of amyloid deposits in biopsy tissue (cardiac or non-cardiac).
•c. Transthyretin precursor protein identification by immunohistochemistry.
•d. Evidence of cardiac involvement on echocardiography with an end-diastolic interventricular septal wall thickness >12mm.
•2. Variant transthyretin-derived cardiac amyloidosis
•a. Cardiomyopathy symptoms and a transthyretin gene mutation associated with cardiomyopathy.
•b. Medical history of hospitalization for heart failure or a heart failure condition requiring treatment with a diuretic for improvement.
•c. Evidence of cardiac involvement on echocardiography with an end-diastolic interventricular septal wall thickness >12mm.
•d. Presence of amyloid deposits in biopsy tissue (cardiac or non-cardiac).

•1) Subjects with a history of hypersensitivity to glavonoid.
•2) Subjects who have been taking tafamidis, diflunisal, or glavonoid 8 weeks prior to the initiation of screening.
•3) Subjects receiving treatment with patisiran or vutrisiran.
•4) Subjects with confirmed transthyretin gene abnormality and polyneuropathy.
•5) Pregnant subjects.
•6) Subjects with significant hepatic disorders (ALT or AST levels more than 3 times higher than normal values) or liver cirrhosis.
•7) Subjects judged to be inappropriate to participate in this study by investigators.

发起方

Tahara Nobuhiro