臨床研究等提出・公開システム

Date of registration	Nov. 22, 2024
Last modified on	Oct. 03, 2025
Trial ID	jRCT2071240078

Scientific Title	Open-label extension study of long-term safety and efficacy of NNC6019-0001 in participants with transthyretin amyloid cardiomyopathy (ATTR CM)(NN6019-7565)
Public Title	A research study to look at long-term treatment with a medicine called NNC6019-0001 for people who have heart failure due to transthyretin amyloidosis(NN6019-7565)

Contact for Scientific Queries	Name	Ito Junji
	Affiliation	Novo Nordisk Pharma Ltd.
	Address	2-1-1, Marunouchi, Chiyodaku, Tokyo
	Telephone	+81-362661000
	E-mail	JPHC_clinical_trials@novonordisk.com
Contact for Public Queries	Name	person in charge of registering clinical trial information
	Affiliation	Novo Nordisk Pharma Ltd.
	Address	2-1-1, Marunouchi, Chiyodaku, Tokyo
	Telephone	+81-362661000
	E-mail	JPHC_clinical_trials@novonordisk.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 03, 2024
Target sample size		7
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	-Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. -Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
	Exclusion Criteria	-A prior solid organ transplant. -Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening. -Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response. -Body weight > 120 kg (264.6 lb) at screening.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Transthyretin amyloid cardiomyopathy (wtATTR and hATTR)
Intervention(s)		To administer i.v. 10 mg/kg NNC6019-0001 Q4W added to standard of care
Primary Outcome(s)		To assess the long-term safety and tolerability of NNC6019-0001 from baseline up to week 156 in participants with hATTR or wtATTR cardiomyopathy.

Primary Sponsor	Novo Nordisk Pharma Ltd.

Name of Certified Review Board	IRB of Kumamoto University Hospital
Address	1-1-1 Honjo, Chuo-ku, Kumamoto-City, Kumamoto, Kumamoto
Telephone	+81-96-373-5842
E-Mail	chikenjimu@kuh.kumamoto-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 02, 2024

Plan to share IPD	Yes
Plan description	According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Secondary ID(s)	NCT06260709
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	United states/Canada/Czech Republic/France/Germany/Italy/Netherlands/Portugal/Spain

History of Changes

No	Publication date
2	Oct. 03, 2025	(this page)	Changes
1	Nov. 22, 2024	Detail

List of change history