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

NCT07445087 | Not Yet Recruiting

• 1 other identifier: SHP643-405
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hereditary Angioedema (HAE)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

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

Interventions

No intervention OTHER

This is a non-interventional study.

All Participants

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Related 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.

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 29, 2032
• Study Completion (Estimated): February 29, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.