Current partner codePEPTIDESDE
NCT05489640·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

85

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

OTHER

No Intervention

No Intervention will be administered in this study.

Timeline

From registration to results.

  1. First posted

    Aug 5, 2022

  2. Study start

    Nov 18, 2022

  3. Primary completion

    Jul 17, 2024

  4. Study completion

    Jul 17, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 5, 2024

Outcomes

What the study measures.

Primary outcomes

Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index

Time frame · 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

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

Secondary outcomes

Number of Participants Categorized by Their Demographic Characteristics

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

Demographic characteristics will include age at index (categories: 18-29, 30-39, 40-49, 50-59, 60+ years), sex (male, female, non-binary), and ethnic group.

Number of Participants Categorized by Their Clinical Characteristics

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

Clinical characteristics will include patient reported HAE type (Type I or Type II), categories of duration (participant's self-administration of icatibant at home and time since HAE diagnosis) at index, comorbidities, prior HAE related concomitant medication details, categories of details of deaths during the study observation period.

Rate of New HAE Attacks

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

Rate of new HAE attacks and rate of new HAE attacks that required treatment in homecare setting will be recorded as number of HAE attacks per participant per month. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.

Frequency of Visits to Accident and Emergency Services Related to an HAE Attack

Time frame · 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 will be defined as number of visits to Accidents and Emergency Services during pre-defined time period. Data would be reported for pre-defined time-period categories as follows: between index to month 3, between month 3 to 6, month 6 to 9 and month 9 to 12.

Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting

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

The summary data for time (in hours) from the start of each HAE attack to administration of icatibant in the homecare setting will be reported.

Frequency of Icatibant Administration Following Start of Each HAE Attack

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

The summary data for number of icatibant administration following start of each HAE attack during the predefined time period will be reported.

Number of Participants by Treatment Patterns

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

Treatment patterns will include assessment of number of participants by treatment dose received for HAE attack and average dose per participant received post-index.

Number of Participants by Treatment Management Patterns

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

Treatment management patterns will include assessment of number of participants by discontinuations of icatibant treatment and reasons for discontinuation (this would be assessed for participants who received prophylaxis treatment during the study), number of face-to-face and telephone-based homecare consultations.

EQ-5D-5L Score

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

The EQ-5D-5L questionnaire will be used to record impact of HAE on participant's quality-of-life (QoL). The EQ-5D-5L is a descriptive system of Health-Related Quality-of-Life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take 1 of 5 responses. The responses record 5 levels of severity \[no problems, slight problems, moderate problems, severe problems, and extreme problems\] within a particular dimension. The scores will be the sum of scores from each dimension and can range from 5 (no problems) to 25 (extreme problems).

AE-QoL Total Score

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

The Angioedema Quality of Life (AE-QoL) includes 17 items and 4 domains: functioning, fatigue/mood, fears/shame, and food. Raw scores from each domain will be linearly transformed to a total score of 0 to 100, with higher scores indicating a stronger impairment.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Sciensus

London, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Icatibant.

Related PeptideStat pages

Put the record in context.

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