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

NCT05489640 | Completed

• 2 other identifiers: TAK-667-4002MACS-2021-061502
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Hereditary Angioedema (HAE)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Number of Participants Categorized by Their Demographic Characteristics

  Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)]

• Number of Participants Categorized by Their Clinical Characteristics

  At Index (day of the first homecare telephonic consultation/visit)

• Rate of New HAE Attacks

  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

  Up to 12 months from Index (day of the first homecare telephonic consultation/visit)

• 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)

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention will be administered in this study.

HAE Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with a diagnosis of HAE I or II 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Sciensus

London, W2 6LA, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: November 18, 2022
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GB (1)