NCT07428499招募中3 期
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 50
- 主要终点
- Safety of ADX-324 in Participants with HAE
研究概览
简要总结
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Have a documented diagnosis of HAE (Type I or II)
- •Completed Study ADX-324-301
- •Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
排除标准
- •A negative reaction to study drug in ADX-324-301
研究组 & 干预措施
ADX-324 Dose Level 2
Experimental
干预措施: ADX-324 Dose Level 2 (Drug)
ADX-324 Dose Level 1
Experimental
干预措施: ADX-324 Dose Level 1 (Drug)
结局指标
主要结局
Safety of ADX-324 in Participants with HAE
时间窗: Month 36
Incidence and severity of treatment-emergent adverse events
次要结局
- Efficacy of ADX-324 in Preventing HAE Attacks(Month 36)
研究者
研究点 (50)
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