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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is a non-interventional study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to approximately 12 months |
| Number of Participants With Expected and Unexpected AEs and SAEs | Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome. | Up to approximately 12 months |
| Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs | 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. | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HAE Attacks | Number of HAE attacks will be estimated across the pre- and post-treatment periods. | Up to approximately 12 months |
| Monthly HAE Attack Rate | Monthly HAE attack rate is defined as the number of HAE attacks collected from each study participant, adjusted to 28 days (1 month). |
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Inclusion criteria:
Exclusion criteria:
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Participants diagnosed with HAE who are currently receiving Takhzyro or who initiate Takhzyro treatment for the first time.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| Label | URL |
|---|---|
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
| Click here for more information about this trial in easy-to-understand language. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| Up to approximately 12 months |
| Number of HAE Attacks Requiring Acute Treatment | Number of HAE attacks requiring acute treatment will be reported. | Up to approximately 12 months |
| Monthly HAE Attack Rate Requiring Acute Treatment | Monthly HAE attack rate requiring acute treatment will be reported. | Up to approximately 12 months |
| Number of Moderate or Severe HAE Attacks | Number of participants with HAE attack based on attack severity (Mild, moderate or severe) will be reported. | Up to approximately 12 months |
| Monthly HAE Attack Rate With Moderate or Severe Severity | Monthly HAE attack rate with moderate or severe severity will be reported. | Up to approximately 12 months |
| Change From Baseline in the Monthly HAE Attack Rate | Change from baseline in the monthly HAE attack rate will be reported. | Up to approximately 12 months |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |