A Survey of Lanadelumab in Participants With Hereditary Angioedema

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time.

Exclusion criteria

None

Treatment and study plan

Lanadelumab

Drug

Lanadelumab 300 mg, subcutaneous injection every 2 weeks

Other names: SHP643 (TAK-743), TAKHZYRO

Primary outcomes

Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

Time frame: 12 Months

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.

Secondary outcomes

Number of Angioedema Attacks

Time frame: 12 Months

Number of angioedema attacks during the study will be assessed.
Angioedema Quality of life (AE-QoL) Questionnaire

Time frame: 12 Months

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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Specific Use-Results Survey of TAKHZYRO Subcutaneous Injection 300 mg Syringe for Hereditary Angioedema With Long-term Administration

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: May 31, 2022
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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