Hereditary angioedema (HAE)
Conditions
Interventions
Group 1: Patients aged 12 years and older with HAE type 1 or type 2 with C1-INH deficiency,
identified by HAE treatment centers in Germany, will complete an online questionnaire (depending on the sele
Sponsors
KalVista Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: • Must have a self-reported physician diagnosis of HAE type I or II C1-INH HAE • Must be aged 12 years or older • [Primary Objective: Last Treated Attack survey] Occurrence of 1 or more treated HAE attack of any severity within the last 3 months. (This period may be expanded as necessary depending on study enrollment.) Treatment must have been with, depending upon country specific indications: • Firazyr (icatibant) • Icatibant (generic) • Berinert (C1 esterase inhibitor) • Ruconest (C1 esterase inhibitor) • Kalbitor (ecallantide) • Cinryze (human C1 esterase inhibitor) • [For Secondary Objective only: Last Untreated Attack survey] Most recent attack that was untreated and occurred within the past 3 months (this period may be expanded as necessary depending on study enrollment) • Able to read and respond to a survey in the local language • Informed Consent / Assent o Adolescents: Patients aged 12-17 years (or age of majority) provide assent to participate; parents of adolescent patients (aged 12-17 years (or age of majority) inclusive) provide informed consent o Adults: Able to provide informed consent
Exclusion criteria
Exclusion criteria: • Currently participating in an HAE clinical trial at the time of the survey or participated in a clinical trial in the past 3 months (this period may be expanded as necessary depending on study enrollment) of the survey
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Characterize patient perceptions of the physical, mental, and social domains of the burden related to treated attacks and associated treatments •Characterize patient descriptions of attack severity •Describe impact of time to on-demand treatment on health-related quality of life •Quantify the indirect economic burden associated with treatment of HAE | — |
Secondary
| Measure | Time frame |
|---|---|
| • Characterize patient perceptions of the physical, mental, and social domains of the burden related to untreated attacks • Describe the barriers to treatment | — |
Countries
Germany
Contacts
Public ContactThomas Buttgereit
Charité – Universitätsmedizin Berlin
Outcome results
None listed