NL-OMON51443尚未招募2 期
Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM) - NN6019-4940
ovo Nordisk0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female.
- •Age >= 18 to < 85 years at the time of signing informed consent.
- •Have an established diagnosis of ATTR CM with either wild-type TTR or
- •hereditary TTR
- •genotype as per local standards.
- •Expected to be on stable doses of cardiovascular medical therapy 6 weeks
- •prior to the
- •randomisation visit.
- •Known end-diastolic interventricular septal wall thickness >= 12 mm.
- •Presently classified as New York Heart Association (NYHA) Class II-III.
- •NT-proBNP concentration >=650 pg/mL in sinus cardiac rhythm and >1000 pg/mL in
- •atrial fibrillation
- •at screening.
- •Completed >=150 meters to <=450 meters on the 6-MWT at screening.
- •Estimated glomerular filtration rate (eGFR) >=25 mL/min/1.73 m2 at screening.
排除标准
- •Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy
- •due to hypertension, valvular heart disease, or ischemic heart disease
- •A prior solid organ transplant
- •Planned solid organ transplant during the study
- •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
- •Acute coronary syndrome, unstable angina, stroke, transient ischemic attack
- •(TIA), coronary revascularization, cardiac valve repair, or major surgery
- •within 3 months of screening
- •Body weight >120 kg (264.6 lb) at screening
- •History of contrast allergy or adverse reactions to gadolinium-containing
研究者
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