NCT04883905招募中不适用
ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)
Alnylam Pharmaceuticals31 个研究点 分布在 10 个国家目标入组 150 人开始时间: 2021年4月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 31
- 主要终点
- Incidence of Selected Events of Interest in AHP Patients
研究概览
简要总结
This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of AHP, per physician's determination
排除标准
- •Currently enrolled in a clinical trial for any investigational agent
研究组 & 干预措施
Patients with AHP
Patients with a diagnosis of AHP will be eligible for the study and will be managed and treated per routine clinical practice.
结局指标
主要结局
Incidence of Selected Events of Interest in AHP Patients
时间窗: Up to 6 years
Selected events of interest are defined as hepatic events (including hepatic neoplasia), renal events, thromboembolic events, and pancreatitis.
次要结局
- Annualized Rate of Porphyria Attacks(Up to 6 years)
- 12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version)(Up to 6 years)
研究者
研究点 (31)
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