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)

JRCT ID: jRCT2071240078

Registered date:22/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Transthyretin amyloid cardiomyopathy (wtATTR and hATTR)
• Date of first enrollment: 03/12/2024
• Target sample size: 7
• Countries of recruitment: United states,Japan,Canada,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Portugal,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): To administer i.v. 10 mg/kg NNC6019-0001 Q4W added to standard of care

Outcome(s)

• Primary Outcome: To assess the long-term safety and tolerability of NNC6019-0001 from baseline up to week 156 in participants with hATTR or wtATTR cardiomyopathy.

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ito Junji
• Secondary ID(s): NCT06260709