臨床研究等提出・公開システム

Date of registration	Jan. 30, 2023
Last modified on	Mar. 12, 2025
Trial ID	jRCT2051220160

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

Contact for Scientific Queries	Name	Akita Yasuhiko
	Affiliation	TOA EIYO LTD.
	Address	3-10-6, Hatchobori, Chuo-ku, TOKYO
	Telephone	+81-3-6757-1040
	E-mail	ct_info@toaeiyo.co.jp
Contact for Public Queries	Name	Clinical Development Dept.
	Affiliation	TOA EIYO LTD.
	Address	3-10-6, Hatchobori, Chuo-ku, TOKYO
	Telephone	+81-3-6757-1040
	E-mail	ct_info@toaeiyo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 30, 2023
Actual date of first enrollment		Feb. 06, 2023
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion Criteria	Patients with diabetic ketoacidosis. Patients allergic to the ingredients of the investigational product.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Idiopathic triglyceride deposit cardiomyovasculopathy
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).
Primary Outcome(s)		Adverse event, Adverse drug reaction

Primary Sponsor	TOA EIYO LTD.

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Osaka University Hospital
Address	2-15 Yamadaoka, Suita,, Osaka
Telephone	+81-662108290
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 16, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 12, 2025	(this page)	Changes
4	July. 16, 2024	Detail	Changes
3	Jan. 22, 2024	Detail	Changes
2	June. 12, 2023	Detail	Changes
1	Jan. 30, 2023	Detail

List of change history