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NCT06587464·Not applicable·OBSERVATIONAL

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

IcatibantOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

19

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

OTHER

No Intervention

This is a non-interventional study.

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Oct 16, 2024

  3. Primary completion

    Dec 18, 2024

  4. Study completion

    Dec 18, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Feb 10, 2025

Outcomes

What the study measures.

Primary outcomes

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.

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.

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).

Average Time Interval Between HAE Attacks in Days

Time frame · Up to 11 months

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

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.

Percentage of Icatibant-Treated HAE Attacks Among All HAE Attacks

Time frame · Up to 11 months

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.

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).

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

Seoul National University Hospital

Seoul, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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