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OpenTrials
Completed

NCT Number: NCT06587464

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

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.

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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

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. HAE Attack Rate

    Time frame: 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.

  2. Percentage of Participants With HAE Attack Based on Location

    Time frame: 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.

  3. Percentage of Participants With HAE Attack Based on Attack Severity

    Time frame: 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).

  4. Average Time Interval Between HAE Attacks in Days

    Time frame: Up to 11 months

  5. Percentage of Participants With Prodromal Symptom

    Time frame: 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 outcomes

  1. Icatibant-treated HAE Attack Rate

    Time frame: 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.

  2. Percentage of Icatibant-Treated HAE Attacks Among All HAE Attacks

    Time frame: Up to 11 months

  3. Number of HAE Attacks Categorized Based on the Icatibant Administration in a Single Attack

    Time frame: Up to 11 months

    The number of icatibant administration in a single attack will be reported as either none, once, or twice.

  4. Number of Participants Categorized Based on Demographic Characteristics

    Time frame: At Baseline

    Number of participants will be reported by their demographic characteristics (age, sex, disease duration and baseline danazol use).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Exploring Symptom Profile and Treatment Patterns in Korean HAE Patients Using Digital Patient Diary: A Retrospective Descriptive Study (SPEAKUP Study)

Acronym: SPEAKUP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Feb 10, 2025

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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