Clinical trial NCT06587464: A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People
Official title: Exploring Symptom Profile and Treatment Patterns in Korean HAE Patients Using Digital Patient Diary: A Retrospective Descriptive Study (SPEAKUP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema (HAE)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HAE type I or II participants who are prescribed icatibant, enrolled in the OnHeart PSP, and registered in and actively utilized mobile app application for at least 1 month will be included in this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HAE Attack Rate
timeFrame: Up to 11 months
measure: Percentage of Participants With HAE Attack Based on Location
timeFrame: Up to 11 months
measure: Percentage of Participants With HAE Attack Based on Attack Severity
timeFrame: Up to 11 months
measure: Average Time Interval Between HAE Attacks in Days
timeFrame: Up to 11 months
measure: Percentage of Participants With Prodromal Symptom
timeFrame: Up to 11 months
Secondary outcomes:
measure: Icatibant-treated HAE Attack Rate
timeFrame: Up to 11 months
measure: Percentage of Icatibant-Treated HAE Attacks Among All HAE Attacks
timeFrame: Up to 11 months
measure: Number of HAE Attacks Categorized Based on the Icatibant Administration in a Single Attack
timeFrame: Up to 11 months
measure: Number of Participants Categorized Based on Demographic Characteristics
timeFrame: At Baseline
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: