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Not yet recruiting NCT07445087

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

— Observational Hereditary Angioedema (HAE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Hereditary Angioedema (HAE). Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No intervention
    This is a non-interventional study.

Primary outcome measures

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to approximately 12 months]
  • Number of Participants With Expected and Unexpected AEs and SAEs [Time frame: Up to approximately 12 months]
  • 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]
Secondary outcome measures (7)
  • Number of HAE Attacks [Time frame: Up to approximately 12 months]
  • Monthly HAE Attack Rate [Time frame: Up to approximately 12 months]
  • Number of HAE Attacks Requiring Acute Treatment [Time frame: Up to approximately 12 months]
  • Monthly HAE Attack Rate Requiring Acute Treatment [Time frame: Up to approximately 12 months]
  • Number of Moderate or Severe HAE Attacks [Time frame: Up to approximately 12 months]
  • Monthly HAE Attack Rate With Moderate or Severe Severity [Time frame: Up to approximately 12 months]
  • Change From Baseline in the Monthly HAE Attack Rate [Time frame: Up to approximately 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07445087 · SHP643-405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗