NCT05511922已完成3 期
A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 64
- 主要终点
- Pharmacokinetics - Tmax
研究概览
简要总结
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
- •Patient is currently participating in KVD900-
- •Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
- •Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.
排除标准
- •Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.
研究组 & 干预措施
KVD900 600 mg
Experimental
干预措施: KVD900 600 mg (Drug)
结局指标
主要结局
Pharmacokinetics - Tmax
时间窗: Up to 6 hours after IMP administration
Pharmacokinetics - Cmax
时间窗: Up to 6 hours after IMP administration
Pharmacokinetics - AUC
时间窗: Up to 6 hours after IMP administration
次要结局
未报告次要终点
研究者
研究点 (64)
Loading locations...
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