NCT07216378Available不适用
On Demand Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With Hereditary Angioedema (HAE) With Sebetralstat
适应症
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 6
研究概览
简要总结
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 2 to 11 years of age.
- •Parent or LAR provides signed informed consent and patient provides assent (when applicable).
- •Confirmed diagnosis of HAE.
排除标准
- •Confirmed diagnosis of HAE with nC1-INH or acquired angioedema
- •Patient weighs <9.5 kg
- •Patient participated in the KVD900-303 trial and withdrew prior to trial completion per the protocol or trial closure
- •Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
- •Known hypersensitivity to sebetralstat or its excipients.
- •Patient with a medical history or known to have severe hepatic impairment (Child Pugh C).
- •Patients who require sustained use of strong cytochrome P450 3A4 inhibitors or inducers.
研究者
研究点 (6)
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