Clinical trial NCT05489640: A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema (HAE)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Number of Participants Treated with Icatibant in the Homecare Setting in Each Prophylactic Treatment Type
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Secondary outcomes:
measure: Number of Participants Categorized by Their Demographic Characteristics
timeFrame: Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)]
measure: Number of Participants Categorized by Their Clinical Characteristics
timeFrame: At Index (day of the first homecare telephonic consultation/visit)
measure: Rate of New HAE Attacks
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Frequency of Visits to Accident and Emergency Services Related to an HAE Attack
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Frequency of Icatibant Administration Following Start of Each HAE Attack
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Number of Participants by Treatment Patterns
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Number of Participants by Treatment Management Patterns
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: EQ-5D-5L Score
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: AE-QoL Total Score
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
measure: Angioedema Control Test (AECT) Total Score
timeFrame: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Sciensus
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: