A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea (NCT07445087) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
35 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused specifically on tracking adverse events and drug reactions as its main outcomes rather than measuring how well Takhzyro reduces HAE attacks, what does that tell us about what stage of knowledge we're at with this treatment, and should that affect whether we consider enrolling?
2This trial is listed as 'not yet recruiting' in South Korea — is this something that could realistically be an option for us given where we live, and if not, are there comparable studies or access programs available closer to home?
3The study is enrolling teenagers and adults, so given my specific age and health history, does my doctor think I would likely be considered a good candidate to discuss with the trial team when recruitment does open?
4Since Takhzyro already exists as an approved treatment, would my doctor recommend trying it through the standard prescription route first, rather than waiting for this study to begin recruiting and then going through a clinical trial process?
5The trial's primary focus is on collecting safety data including serious adverse drug reactions — what are the known risks of Takhzyro that I should already be aware of before deciding whether this kind of monitoring study would be worth discussing further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to approximately 12 months
2
Number of Participants With Expected and Unexpected AEs and SAEs
Timeframe: Up to approximately 12 months
3
Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs