NCT07383025招募中不适用
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月21日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) and/or serious AEs (SAEs)
研究概览
简要总结
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All obstructive hypertrophic cardiomyopathy (oHCM) patients who initiate treatment with Mavacamten of the approved indications at medical institutions in Japan during enrollment period will be enrolled in this regulatory post-marketing surveillance (PMS) study
排除标准
- •Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study
研究组 & 干预措施
Cohort 1
Participants with obstructive hypertrophic cardiomyopathy receiving mavacamten treatment
干预措施: Mavacamten (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and/or serious AEs (SAEs)
时间窗: Up to 52 weeks
Actions taken after adverse events (AEs) and/or serious AEs (SAEs)
时间窗: Up to 52 weeks
Outcome of adverse events (AEs) and/or serious AEs (SAEs)
时间窗: Up to 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled SyringeNCT07282795Sanofi670
Enrolling By Invitation
不适用
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDNHypertensionNCT07273877Shanghai Golden Leaf MedTec Co. Ltd1,000
尚未招募
不适用
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in AdultsHearing LossNCT07338864Cochlear66
终止
不适用
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous UrticariaNCT07316114Sanofi1
尚未招募
不适用
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery DiseaseNCT07338890Cordis US Corp.240