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

Active, not recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
HAE Participants (Type I or II)	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
HAE Attack Rate	Up to 11 months	The HAE attack rate will be calculated as a per participant per month (PPPM) rate. The PPPM rate will be calculated by dividing the total number of attacks reported per each HAE participant during their observation periods by their duration of observation periods in months.
Percentage of Participants With HAE Attack Based on Location	Up to 11 months	Number of participants with HAE attack based on anatomical location (face, throat, arm, hand, abdomen, genital, leg, foot) will be evaluated.
Percentage of Participants With HAE Attack Based on Attack Severity	Up to 11 months	The HAE attack based on severity will be determined using following definitions: mild (temporarily feels somewhat uncomfortable, swelling is alleviated within 48 hours), moderate (slight disruption in daily life), severe (symptoms that make it impossible to carry out daily life).
Average Time Interval Between HAE Attacks in Days	Up to 11 months
Percentage of Participants With Prodromal Symptom	Up to 11 months	The presence of prodromal symptoms among participants, a response of "No" indicates the absence of any symptoms and a response of "Yes" suggests the presence of one or more symptoms from the following list will be reported: tight and stinging feeling in the skin, anxiety, nausea, sudden emotional changes, non-pruritic rash, severe fatigue, or other symptoms.

Secondary Outcome Measures

Name	Time	Method
Icatibant-treated HAE Attack Rate	Up to 11 months	The icatibant-treated HAE attack rate will be calculated as a PPPM rate. The PPPM rate will be calculated by dividing the total number of icatibant-treated attacks reported per each HAE participant during their observation periods by their duration of observation periods in months.
Percentage of Icatibant-Treated HAE Attacks Among All HAE Attacks	Up to 11 months
Number of HAE Attacks Categorized Based on the Icatibant Administration in a Single Attack	Up to 11 months	The number of icatibant administration in a single attack will be reported as either none, once, or twice.
Number of Participants Categorized Based on Demographic Characteristics	At Baseline	Number of participants will be reported by their demographic characteristics (age, sex, disease duration and baseline danazol use).

Locations (1): Seoul National University Hospital
🇰🇷
Seoul,, Korea, Republic of