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

Takeda

Status: Completed

Conditions: Hereditary Angioedema (HAE)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05489640

TAK-667-4002

MACS-2021-061502 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

85 participants in 1 patient group

HAE Participants

Description:

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.

Treatment:

Other: No Intervention