Hereditary Angioedema (HAE)NCT07445087
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
An observational study of Hereditary Angioedema (HAE), run by Takeda at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- How many people
- 35 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 21 Sep 2026to 29 Feb 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with HAE who are currently receiving Takhzyro or who initiate Takhzyro treatment for the first time.
Who may be able to join
- 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.
Who cannot join
- Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.
- Participant is currently enrolled in an interventional trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Site Contact, helenmed@snu.ac.kr
Hye-Ryun Kang
- Recruiting
Ewha Womans University Hospital
Seoul, 07985
Site Contact, jisu.shim@ewha.ac.kr
Jisu Shim
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Site Contact, ye9007@ajou.ac.kr
Young Min Ye
About this study
Official title: 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.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- No intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months
Secondary outcomes (7)
Number of HAE Attacks
Number of HAE attacks will be estimated across the pre- and post-treatment periods.
Measured: 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).
Measured: Up to approximately 12 months
Number of HAE Attacks Requiring Acute Treatment
Number of HAE attacks requiring acute treatment will be reported.
Measured: Up to approximately 12 months
Monthly HAE Attack Rate Requiring Acute Treatment
Monthly HAE attack rate requiring acute treatment will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start21 Sep 2026
- Primary completion29 Feb 2032 (estimated)
- Study completion29 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445087
- Sponsor's protocol ID
- SHP643-405
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.