NCT07654829尚未招募4 期
A Phase 4, Open-Label Trial to Evaluate the Safety and Effectiveness of Sebetralstat When Used as Preprocedural Short-term Prophylaxis in Patients With Hereditary Angioedema
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥12 years of age at time of Screening
- •Confirmed diagnosis of HAE Type I or II based on patient report
- •Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
- •Patient has access to a commercial available on-demand treatment for HAE
- •Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.
- •(Note: male patients do not require contraception)
- •Patients must be able to swallow trial tablets whole
- •Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire
- •Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
- •Patient provides informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required
排除标准
- •A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator
- •Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
- •Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit
- •Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
- •Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial
- •History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
- •Known hypersensitivity to sebetralstat or to any of the excipients
- •Participation in any gene therapy treatment or trial for HAE
- •Any pregnant or breastfeeding patient
研究组 & 干预措施
KVD900 600 mg
Experimental
干预措施: KVD900 600 mg (Drug)
研究者
研究点 (1)
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