Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 34
- 主要终点
- Number of Treatment Emergent Adverse Events
研究概览
简要总结
This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit
- •Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
排除标准
- •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 greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.
研究组 & 干预措施
NNC6019-0001
Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.
干预措施: NNC6019-0001 (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events
时间窗: From baseline (week 0) up to visit 39 (week 156)
Measured as events.
次要结局
- Change in Global Longitudinal Strain (GLS) on Echocardiography(From baseline (week 0) to visit 28 (week 104))
- Change in Troponin I(From baseline (week 0) to visit 28 (week 104))
- Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)(From baseline (week 0) to visit 28 (week 104))
- Change in Myocardial Extracellular Volume (ECV)(From baseline (week 0) to visit 28 (week 104))
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)(From baseline (week 0) to visit 28 (week 104))
- Change in 6-Minute Walk Test (6MWT)(From baseline (week 0) to visit 28 (week 104))