Clinical trial NCT07009262: A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
Official title: A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Angioedema
Lead sponsor: KalVista Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: US Hereditary Angioedema Association
First posted: 2025-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a self-reported diagnosis of HAE Type I or II who take icatibant to treat HAE attacks

Brief summary: Patients with HAE Type I or II who enroll in the study are asked to complete a patient diary when they experience an HAE attack. If icatibant is taken as the first treatment for the attack, the patient diary will ask questions over a 48 hour period after dosing to track the characteristics and severity of the attack along with the patient's level of anxiety.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients 12 years of age and older
2. Diagnosis of HAE Type I or II, based on US Hereditary Angioedema Association (HAEA) database records and/or verbal confirmation from the patient
3. Currently using icatibant to treat HAE attacks
4. If a patient is receiving long-term prophylactic treatment, they must have been on a stable dose and regimen for at least 3 months prior to the Screening Visit
5. Patient has had at least 2 HAE attacks in the 3 months prior to the Screening Visit, as self-reported verbally by the patient
6. Patient is able to read, understand, and complete the eDiary
7. Patient is willing and able to adhere to all protocol requirements

Exclusion Criteria:

1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria
2. Use of angiotensin-converting enzyme inhibitors
3. Participation in any gene therapy treatment or trial for HAE
4. Participation in any interventional investigational clinical trial within 4 weeks prior to screening
5. Any pregnant or breastfeeding patient

Primary outcomes:
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Within 12 hours of the first Icatibant dose adminstration
Secondary outcomes:
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Within 12 hours of the first Icatibant dose adminstration
measure: PGI-S: Time to Complete HAE Attack Resolution
timeFrame: Within 24 hours of the first Icatibant dose adminstration
measure: Return to normal function
timeFrame: At 48 hours after first Icatibant dose adminstration
measure: General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS
timeFrame: over 12 and 24 hours of the first icatibant administration
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: KalVista Investigative Site
state: Virginia
Study officials:
References: