A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home

Completed

• Conditions: Hereditary Angioedema (HAE)
• Interventions: Other: No Intervention

• Registration Number: NCT05489640
• Lead Sponsor: Takeda

Brief Summary

The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).

Participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the UK. Data will be directly collected from participants via study diaries and questionnaires. Participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-05
• Study Start: 2022-11-18
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HAE Participants	No Intervention	Adult participants with a diagnosis of HAE who are receiving treatment according to routine clinical practice and prescribed all treatments in accordance with the approved marketing authorization will be enrolled in this study. Data will be directly collected from participants via patient reported diaries and paper- based and/or electronic homecare records as appropriate for UK participants using homecare services for icatibant. No study specific intervention will be administered in this study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Number of Participants Treated with Icatibant in the Homecare Setting in Each Prophylactic Treatment Type	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)

Secondary Outcome Measures

Name	Time	Method
Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	The summary data for time (in hours) from the start of each HAE attack to administration of icatibant in the homecare setting will be reported.
Number of Participants by Treatment Patterns	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	Treatment patterns will include assessment of number of participants by treatment dose received for HAE attack and average dose per participant received post-index.
Number of Participants Categorized by Their Clinical Characteristics	At Index (day of the first homecare telephonic consultation/visit)	Clinical characteristics will include patient reported HAE type (Type I or Type II), categories of duration (participant's self-administration of icatibant at home and time since HAE diagnosis) at index, comorbidities, prior HAE related concomitant medication details, categories of details of deaths during the study observation period.
Frequency of Visits to Accident and Emergency Services Related to an HAE Attack	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	Frequency of visits to Accident and Emergency Services related to an HAE attack will be defined as number of visits to Accidents and Emergency Services during pre-defined time period. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.
AE-QoL Total Score	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	The Angioedema Quality of Life (AE-QoL) includes 17 items and 4 domains: functioning, fatigue/mood, fears/shame, and food. Raw scores from each domain will be linearly transformed to a total score of 0 to 100, with higher scores indicating a stronger impairment.
Number of Participants Categorized by Their Demographic Characteristics	Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)]	Demographic characteristics will include age at index (categories: 18-29, 30-39, 40-49, 50-59, 60+ years), sex (male, female, non-binary), and ethnic group.
Number of Participants by Treatment Management Patterns	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	Treatment management patterns will include assessment of number of participants by discontinuations of icatibant treatment and reasons for discontinuation (this would be assessed for participants who received prophylaxis treatment during the study), number of face-to-face and telephone-based homecare consultations.
EQ-5D-5L Score	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	The EQ-5D-5L questionnaire will be used to record impact of HAE on participant's quality-of-life (QoL). The EQ-5D-5L is a descriptive system of Health-Related Quality-of-Life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take 1 of 5 responses. The responses record 5 levels of severity \[no problems, slight problems, moderate problems, severe problems, and extreme problems\] within a particular dimension. The scores will be the sum of scores from each dimension and can range from 5 (no problems) to 25 (extreme problems).
Rate of New HAE Attacks	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	Rate of new HAE attacks and rate of new HAE attacks that required treatment in homecare setting will be recorded as number of HAE attacks per participant per month. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.
Frequency of Icatibant Administration Following Start of Each HAE Attack	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	The summary data for number of icatibant administration following start of each HAE attack during the predefined time period will be reported.
Angioedema Control Test (AECT) Total Score	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)	The AECT is used to assess participants with recurrent angioedema. The test uses a questionnaire with 4 items, each of which has 5 options and is used to measure the participant's current disease control. HAE control score will be recorded with 5 levels of answers \[1=very often, 2=often, 3=sometimes, 4=seldom, 5=not at all\] to the following questions: 1) In the last 3 months, how often have you had angioedema? 2) In the last 3 months, how much has your QoL been affected by angioedema? 3) In the last 3 months, how much has the unpredictability of your angioedema bothered you? 4) In the last 3 months, how well has your angioedema been controlled by your therapy? The total scores are the sum of individual scores from 4 items and will range from 4 (Very often) to 20 (not at all). Higher scores will indicate no recurrence.

Trial Locations

Locations (1)

Sciensus; 🇬🇧 London, United Kingdom