Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy - Safety Study of CNT-01 in Patients with Idiopathic TGCV

Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine0 个研究点目标入组 6 人开始时间: 2015年7月14日最近更新: 2023年10月17日

适应症

试验速览

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•1) Have diabetic ketoacidosis 2) Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years 3) Female with pregnant or lactating 4) Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study 5) Have a New York Heart Association functional classification IV 6) Have a known history of drug dependence 7) Is allergic to any component of the investigational product 8) Is allergic to BMIPP or iodine 9) Have a known history of clinically significant drug allergy 10) Have a severe liver dysfunction (Child classification B and C) 11) Participated in other clinical study within the past 3 months and received an investigational agent including placebo 12) Being treated with diet containing medium chain fatty acid 13) Is considered unfit for the study by the Investigator's medical decision

发起方

Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine