Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy
- Conditions
- Idiopathic Triglyceride Deposit Cardiomyovasculopathy
- Registration Number
- JPRN-UMIN000018289
- Lead Sponsor
- Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method