A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People (SPEAKUP)

Takeda

Status: Completed

Conditions: Hereditary Angioedema (HAE)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06587464

TAK-667-4004

Details and patient eligibility

About

This study intends to gather information on HAE attack symptoms, how often the attacks occur, and the number of times treatment is required to manage the attacks in Korean people over a period of up to 11 months.

The main aims of this study are the following:

• To describe the patterns of HAE attacks, including how often they occur, where they happen in the body, how severe they are, the time between attacks, and any warning signs that appear before an attack.
• To assess how HAE is treated, particularly looking at how on-demand treatments are used during HAE attacks.
• To learn about the people who suffer from HAE attacks (e.g. age, gender, for how long they have been suffering from HAE, and if they use danazol to manage HAE).

In this study, already existing data will be collected and reviewed from a mobile application called "MyHAE Story". The study will only review data collected as part of the clinical routine practice. The study will not impact the standard medical care and treatment of participants.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who are participants in the OnHeart PSP program.
• Participants who have registered in "MyHAE Story" mobile application.

Exclusion criteria

• Participants who neither have made input to at least one attack nor have run the app by clicking 'myHAE story' tab within the Kakaotalk chat message at least once after app registration.

Trial design

19 participants in 1 patient group

HAE Participants (Type I or II)

Description:

Participants with HAE type I or II who are prescribed icatibant, enrolled in the patient support program (PSP), and registered in the "MyHAE Story" mobile app will be included and their data will be collected retrospectively from the first documented date of app until the date of the last recorded attack, participant withdrawal, loss to follow-up, or the end of the study, whichever occurs first.

Treatment:

Other: No Intervention