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

Hereditary Angioedema (HAE) Clinical Trial

Official title:

A Real-World Study to Determine Patient Characteristics, Treatment Patterns, Clinical and Patient-Reported Outcomes of Patients With Hereditary Angioedema That Self-Administered Icatibant Using Homecare Services in the UK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489640
• Other study ID #: TAK-667-4002
• Secondary ID: MACS-2021-061502
• Status: Recruiting
• Start date: November 18, 2022
• Est. completion date: June 26, 2024

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Participants self-administering or receiving care assisted administration of icatibant treatment for patient confirmed diagnosis of HAE Type I or II in the homecare setting

• Participants who are able and willing to complete the study questionnaires

• Participants who are willing to be visited or contacted by a member of the homecare or research team at pre-arranged intervals in order to complete questionnaires

Exclusion Criteria

• Participants who have received icatibant as an investigational medicine as part of a clinical trial

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Other:
• No Intervention
No Intervention will be administered in this study.

Locations

Country	Name	City	State
United Kingdom	Sciensus	London

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Number of Participants Categorized by Their Demographic Characteristics	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.	Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)]
Secondary	Number of Participants Categorized by Their Clinical Characteristics	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.	At Index (day of the first homecare telephonic consultation/visit)
Secondary	Rate of New HAE Attacks	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Frequency of Visits to Accident and Emergency Services Related to an HAE Attack	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Frequency of Icatibant Administration Following Start of Each HAE Attack	The summary data for number of icatibant administration following start of each HAE attack during the predefined time period will be reported.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Number of Participants by Treatment Patterns	Treatment patterns will include assessment of number of participants by treatment dose received for HAE attack and average dose per participant received post-index.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Number of Participants by Treatment Management Patterns	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	EQ-5D-5L Score	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).	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	AE-QoL Total Score	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary	Angioedema Control Test (AECT) Total Score	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.	Up to 12 months from Index (day of the first homecare telephonic consultation/visit)

External Links

•   To obtain more information on the study, click here/on this link.