An Expanded Access Program of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy

JRCT ID: jRCT2051220160

Registered date:30/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic triglyceride deposit cardiomyovasculopathy
• Date of first enrollment: 06/02/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): CNT-01 is administered orally three times daily (in the morning, at noon, and in the evening). The starting dose of CNT-01 is 500 mg (1,500 mg/day) for the first 2 weeks, then the dose is increased to 1000 mg (3,000 mg/day).

Outcome(s)

• Primary Outcome: Adverse event, Adverse drug reaction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who completed the 52 weeks of administration in the CNT-01-811 study.
Patients who voluntarily signed and dated the informed consent form.

Exclude criteria

Patients with diabetic ketoacidosis.
Patients allergic to the ingredients of the investigational product.

Related Information

• Primary Sponsor: Akita Yasuhiko