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NCT Number: NCT07445087

A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea

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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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.
  • Participant is currently enrolled in an interventional trial.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  2. Number of Participants With Expected and Unexpected AEs and SAEs

    Time frame: 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.

  3. Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs

    Time frame: 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

  1. Number of HAE Attacks

    Time frame: Up to approximately 12 months

    Number of HAE attacks will be estimated across the pre- and post-treatment periods.

  2. Monthly HAE Attack Rate

    Time frame: 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).

  3. Number of HAE Attacks Requiring Acute Treatment

    Time frame: Up to approximately 12 months

    Number of HAE attacks requiring acute treatment will be reported.

  4. Monthly HAE Attack Rate Requiring Acute Treatment

    Time frame: Up to approximately 12 months

    Monthly HAE attack rate requiring acute treatment will be reported.

  5. Number of Moderate or Severe HAE Attacks

    Time frame: Up to approximately 12 months

    Number of participants with HAE attack based on attack severity (Mild, moderate or severe) will be reported.

  6. Monthly HAE Attack Rate With Moderate or Severe Severity

    Time frame: Up to approximately 12 months

    Monthly HAE attack rate with moderate or severe severity will be reported.

  7. Change From Baseline in the Monthly HAE Attack Rate

    Time frame: Up to approximately 12 months

    Change from baseline in the monthly HAE attack rate will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Mar 3, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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