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

NCT ID: NCT05489640

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-18

Study Completion Date

2024-07-17

Brief Summary

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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

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HAE Participants

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.

No Intervention

Intervention Type OTHER

No Intervention will be administered in this study.

Interventions

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No Intervention

No Intervention will be administered in this study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Sciensus

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://clinicaltrials.takeda.com/study-detail/ba1ce272a46640c4?idFilter=%5B%22TAK-667-4002%22%5D

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

Other Identifiers

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MACS-2021-061502

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-667-4002

Identifier Type: -

Identifier Source: org_study_id

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