Current partner codePEPTIDESDE
NCT07009262·Not applicable·OBSERVATIONAL

A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks

Status

Completed

Phase

Not applicable

Enrollment

88

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

OTHER

Inapplicable

Inapplicable

Timeline

From registration to results.

  1. First posted

    Jun 6, 2025

  2. Study start

    Apr 21, 2025

  3. Primary completion

    Nov 25, 2025

  4. Study completion

    Nov 25, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 13, 2026

Outcomes

What the study measures.

Primary outcomes

Patient Global Impression of Change (PGI-C)

Time frame · Within 12 hours of the first Icatibant dose adminstration

time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row)

Secondary outcomes

Patient Global Impression of Severity (PGI-S)

Time frame · Within 12 hours of the first Icatibant dose adminstration

Time to first incidence of decrease from baseline (2 time points in a row)

PGI-S: Time to Complete HAE Attack Resolution

Time frame · Within 24 hours of the first Icatibant dose adminstration

time to HAE attack resolution, defined as ''none''

Return to normal function

Time frame · At 48 hours after first Icatibant dose adminstration

Time to return to normal daily activities. Date/Time or one of the following options: * Not Applicable - daily activities were not affected * not yet returned to normal activities

General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS

Time frame · over 12 and 24 hours of the first icatibant administration

Patient is asked 'How anxious do you feel right now?' 11-point numeric scale, 0-10 with 0=Not at all anxious and 10=Extremely anxious

Eligibility

Who can take part.

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

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

Study locations

1 registered sites.

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

KalVista Investigative Site

Fairfax, Virginia, United States

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.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.