A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea
| Registry | NCT07445087 |
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| Status | Recruiting |
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| Study type | Observational |
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| Enrollment | 35 (Estimated) |
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| Sponsor | Takeda (Industry) |
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| Conditions | Hereditary Angioedema (HAE) |
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| Interventions | No intervention (Other) |
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| Dates | start 2026-09-21, primary completion 2032-02-29 (estimated), completion 2032-02-29 (estimated), first posted 2026-03-03, last updated 2026-10-15 |
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| Locations | 3 sites in South Korea |
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-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| All Participants | | Other: No intervention | 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. |
- No intervention (Other): This is a non-interventional study.
+Outcome measures
Primary outcomes
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [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 [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 [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.
Secondary outcomes
- Number of HAE Attacks [Up to approximately 12 months]: Number of HAE attacks will be estimated across the pre- and post-treatment periods.
- Monthly HAE Attack Rate [Up to approximately 12 months]: Monthly HAE attack rate is defined as the number of HAE attacks collected from each study participant, adjusted to 28 days (1 month).
- Number of HAE Attacks Requiring Acute Treatment [Up to approximately 12 months]: Number of HAE attacks requiring acute treatment will be reported.
- Monthly HAE Attack Rate Requiring Acute Treatment [Up to approximately 12 months]: Monthly HAE attack rate requiring acute treatment will be reported.
- Number of Moderate or Severe HAE Attacks [Up to approximately 12 months]: Number of participants with HAE attack based on attack severity (Mild, moderate or severe) will be reported.
- Monthly HAE Attack Rate With Moderate or Severe Severity [Up to approximately 12 months]: Monthly HAE attack rate with moderate or severe severity will be reported.
- Change From Baseline in the Monthly HAE Attack Rate [Up to approximately 12 months]: Change from baseline in the monthly HAE attack rate will be reported.
+Eligibility
Sex: All, ages: 12 Years to any
Inclusion criteria:
1. Participants aged 12 years or older at time of initiation of Takhzyro.
2. Participants who are treated or will be treated with Takhzyro according to the approved label of South Korea.
3. The participant or legally authorized representative agrees to participate.
Exclusion criteria:
1. Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.
2. Participant is currently enrolled in an interventional trial.
+Locations (3)
| Facility | City | Country | Status |
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| Ajou University Hospital | Suwon, Gyeonggi-do | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Ewha Womans University Hospital | Seoul | South Korea | Recruiting |
+Investigators
- Study Director, Study director, Takeda