NCT07009262已完成不适用
A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Patient Global Impression of Change (PGI-C)
研究概览
简要总结
Patients with HAE Type I or II who enroll in the study are asked to complete a patient diary when they experience an HAE attack. If icatibant is taken as the first treatment for the attack, the patient diary will ask questions over a 48 hour period after dosing to track the characteristics and severity of the attack along with the patient's level of anxiety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 and older
- •Diagnosis of HAE Type I or II, based on US Hereditary Angioedema Association (HAEA) database records and/or verbal confirmation from the patient
- •Currently using icatibant to treat HAE attacks
- •If a patient is receiving long-term prophylactic treatment, they must have been on a stable dose and regimen for at least 3 months prior to the Screening Visit
- •Patient has had at least 2 HAE attacks in the 3 months prior to the Screening Visit, as self-reported verbally by the patient
- •Patient is able to read, understand, and complete the eDiary
- •Patient is willing and able to adhere to all protocol requirements
排除标准
- •Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria
- •Use of angiotensin-converting enzyme inhibitors
- •Participation in any gene therapy treatment or trial for HAE
- •Participation in any interventional investigational clinical trial within 4 weeks prior to screening
- •Any pregnant or breastfeeding patient
研究组 & 干预措施
Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks.
干预措施: Inapplicable (Other)
结局指标
主要结局
Patient Global Impression of Change (PGI-C)
时间窗: Within 12 hours of the first Icatibant dose adminstration
time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row)
次要结局
- Patient Global Impression of Severity (PGI-S)(Within 12 hours of the first Icatibant dose adminstration)
- PGI-S: Time to Complete HAE Attack Resolution(Within 24 hours of the first Icatibant dose adminstration)
- Return to normal function(At 48 hours after first Icatibant dose adminstration)
- General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS(over 12 and 24 hours of the first icatibant administration)
研究者
研究点 (2)
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