A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Takhzyro is an approved treatment for hereditary angioedema (HAE) in South Korea. HAE is a rare condition which causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. The main aim of this study is to check how safe Takhzyro is in teenagers and adults with HAE in everyday medical care in South Korea. Another aim is to see how well Takhzyro works in everyday medical care.
The treatment of participants and any check-ups will be determined by the treating doctors according to their normal practice. Participants may visit the study clinic several times during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participants aged 12 years or older at time of initiation of Takhzyro.
- •Participants who are treated or will be treated with Takhzyro according to the approved label of South Korea.
- •The participant or legally authorized representative agrees to participate.
排除标准
- •Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.
- •Participant is currently enrolled in an interventional trial.
研究组 & 干预措施
All Participants
Adolescent and adult participants diagnosed with HAE who are receiving Takhzyro or initiating Takhzyro treatment for the first time in routine clinical practice will be included. Both retrospective and prospective data will be collected for up to 6 years. Treatment and follow-up will be determined by the treating physicians according to routine clinical practice.
干预措施: No intervention (Other)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to approximately 12 months
An AE is any untoward medical occurrence in a study participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
Number of Participants With Expected and Unexpected AEs and SAEs
时间窗: Up to approximately 12 months
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs
时间窗: Up to approximately 12 months
An ADR is an AE for which there is at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. Unexpected ADR is defined as an ADR that differs from the information in the ADR section of the product label in nature, severity, specificity, or outcome.
次要结局
- Number of HAE Attacks(Up to approximately 12 months)
- Monthly HAE Attack Rate(Up to approximately 12 months)
- Number of HAE Attacks Requiring Acute Treatment(Up to approximately 12 months)
- Monthly HAE Attack Rate Requiring Acute Treatment(Up to approximately 12 months)
- Number of Moderate or Severe HAE Attacks(Up to approximately 12 months)
- Monthly HAE Attack Rate With Moderate or Severe Severity(Up to approximately 12 months)
- Change From Baseline in the Monthly HAE Attack Rate(Up to approximately 12 months)