HAE patients self-administering icatibant in the home setting
Research type
Research Study
Full 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
IRAS ID
312089
Contact name
Patrick Young
Contact email
Sponsor organisation
Takeda
Duration of Study in the UK
1 years, 3 months, 12 days
Research summary
The purpose of this non-interventional study is to gain insight as to the characteristics, treatment, and outcomes for patients diagnosed with Hereditary Angioedema (HAE) who self administer Icatibant for the acute treatment of an HAE attack using homecare services.
Icatibant is a medicine licensed to treat the symptoms of attacks of HAE in adults, adolescents and children aged over 2 years. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Attacks of HAE can be life threatening when they involve the throat. Icatibant is used in patients whose angioedema is linked to a deficiency of a protein called ‘C1 esterase inhibitor’.
There is existing evidence supporting the clinical and cost-effectiveness administration of icatibant at home, however there is currently limited real-world data regarding specific characteristics and outcomes of patient who are currently receiving icatibant in the homecare setting within the United Kingdom. Therefore, the primary objective of this study is to describe the proportion of patients treated with icatibant in the homecare setting who are also receiving preventative treatment and the types of preventative treatment received.
Patient demographics and clinical characteristics will be extracted from the homecare medical records where available and collected prospectively from patients during enrolment into the study. The details of treatments receive during the study (both preventative and acute treatments) and HAE attacks experienced will be collected through diaries provided. Outcomes relating to the patients quality of life will be assessed using validated questionnaires and collected at 3 monthly intervals during the study.
Approximately 100 patients will be recruited through 1 homecare provider, and followed up for 12 months after enrolment into the study. These patients will be above 18 years old and have a confirmed diagnosis of HAE.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/PR/0993
Date of REC Opinion
3 Aug 2022
REC opinion
Favourable Opinion