jRCT2071240078招募中不适用
Open-label extension study of long-term safety and efficacy of NNC6019-0001 in participants with transthyretin amyloid cardiomyopathy (ATTR CM)(NN6019-7565)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 主要终点
- long-term safety and tolerability
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
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 > 120 kg (264.6 lb) at screening.
结局指标
主要结局
long-term safety and tolerability
时间窗: from baseline up to week 156
To assess the long-term safety and tolerability of NNC6019-0001 in participants with hATTR or wtATTR cardiomyopathy
次要结局
未报告次要终点
研究者
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