Hereditary Angioedema (HAE)NCT05397431
A Survey of Lanadelumab in Participants With Hereditary Angioedema
An observational study of Hereditary Angioedema (HAE), run by Takeda at 1 site in Japan.
Trial summary
This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- Lanadelumab
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 1 siteJapan
- Study dates
- 30 May 2022to 27 Oct 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Use-Results Survey of TAKHZYRO Subcutaneous Injection 300 mg Syringe for Hereditary Angioedema With Long-term Administration
This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Lanadelumab and to check if Lanadelumab improves symptoms of HAE. During the study, participants with HAE will take Lanadelumab subcutaneous injection according to their clinic's standard practice. The study doctors will check for side effects from Lanadelumab for 12 months.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- Lanadelumab
- 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.
LanadelumabDrug
Also called SHP643 (TAK-743), TAKHZYRO
Lanadelumab 300 mg, subcutaneous injection every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lanadelumab | Participants will receive 300 milligram (mg) of Lanadelumab Subcutaneous (SC) injection once every 2 weeks. Receives: Drug: Lanadelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: 12 Months
Secondary outcomes (2)
Number of Angioedema Attacks
Number of angioedema attacks during the study will be assessed.
Measured: 12 Months
Angioedema Quality of life (AE-QoL) Questionnaire
The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema (including HAE). The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AE-QoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five-point response scale ranging from 1 (Never) to 5 (Very Often).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 May 2022
- Primary completion27 Oct 2026 (estimated)
- Study completion27 Oct 2026 (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
- Prospective
- Enrolment
- 155 participants (actual)
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
- NCT05397431
- Sponsor's protocol ID
- TAK-743-4004
- Other IDs
- jRCT2031220105
- Status last verified
- Aug 2026
- First submitted
- 26 May 2022
- Last updated
- 4 Aug 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.