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

A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hereditary Angioedema (HAE)
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with HAE who are currently receiving Takhzyro or who initiate Takhzyro treatment for the first time.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• 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.
• Click here for more information about this trial in easy-to-understand language.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 29, 2032
• Study Completion (Estimated): February 29, 2032

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immunologic Deficiency Syndromes; Skin Diseases; Urticaria; Skin Diseases, Vascular; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Angioedema; Angioedemas, Hereditary
• Other Study ID Numbers: SHP643-405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No