CompletedPhase 1/2

Safety Study of CNT-01 in Patients With Idiopathic TGCV

Japan5 participantsStarted 2015-09

Plain-language summary

The purpose of this study is to assess the safety and to examine the index of the efficacy after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy * After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient * More than 20 years old at the time of informed consent * Is able to oral intake * Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy Exclusion Criteria: * Have diabetic ketoacidosis * Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years * Female with pregnant or lactating * 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 * Have a New York Heart Association functional classification IV * Have a known history of drug dependence * Is allergic to any component of the investigational product * Is allergic to BMIPP or iodine * Have a known history of clinically significant drug allergy * Have a severe liver dysfunction (Child classification B and C) * Participated in other clinical study within the past 3 months and received an investigational agent including placebo * Being treated with diet containing medium chain fatty acid * Is considered unfit for the study by the Investigator's medical decision

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of adverse event

Timeframe: Baseline to Day 29

Change in 12-lead ECG recordings from Baseline

Timeframe: Baseline to Day 29

Change in Blood Pressure from Baseline

Timeframe: Baseline to Day 29

Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)

Timeframe: Baseline to Day 29

Change in Body temperature from Baseline

Timeframe: Baseline to Day 29

Change in Pulse rate from Baseline

Timeframe: Baseline to Day 29

Trial details

NCT IDNCT02502578

SponsorOsaka University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Idiopathic Triglyceride Deposit Cardiomyovasculopathy trials

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of adverse event

Timeframe: Baseline to Day 29

Change in 12-lead ECG recordings from Baseline

Timeframe: Baseline to Day 29

Change in Blood Pressure from Baseline

Timeframe: Baseline to Day 29

Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)

Timeframe: Baseline to Day 29

Change in Body temperature from Baseline

Timeframe: Baseline to Day 29

Change in Pulse rate from Baseline

Timeframe: Baseline to Day 29