NCT06628713Approved For Marketing不适用
On Demand Treatment of Angioedema Attacks in Adolescent and Adult Post-Trial and Naive Patients 12 Years and Older With Hereditary Angioedema (HAE) Type I or II With Sebetralstat
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 1
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 Type I or II Hereditary Angioedema (HAE) adolescent and adult 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age.
- •Able to provide written, informed consent or assent.
- •Confirmed diagnosis of HAE Type I or II.
排除标准
- •Confirmed diagnosis of HAE with nC1-INH or acquired angioedema.
- •Confirmed pregnancy or breast-feeding.
- •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 (1)
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