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Completed

NCT Number: NCT07009262

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

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.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KalVista Investigative Site

Fairfax, Virginia, 22030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients 12 years of age and older
  • Diagnosis of HAE Type I or II, based on US Hereditary Angioedema Association (HAEA) database records and/or verbal confirmation from the patient
  • Currently using icatibant to treat HAE attacks
  • 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
  • Patient has had at least 2 HAE attacks in the 3 months prior to the Screening Visit, as self-reported verbally by the patient
  • Patient is able to read, understand, and complete the eDiary
  • Patient is willing and able to adhere to all protocol requirements

Exclusion criteria

  • 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
  • Use of angiotensin-converting enzyme inhibitors
  • Participation in any gene therapy treatment or trial for HAE
  • Participation in any interventional investigational clinical trial within 4 weeks prior to screening
  • Any pregnant or breastfeeding patient

Treatment and study plan

inapplicable

Other

Inapplicable

Primary outcomes

  1. 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

  1. 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)

  2. 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''

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

KalVista Pharmaceuticals, Ltd.

Industry

Collaborators

  • US Hereditary Angioedema Association

Registry information

Official study title

A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks

Acronym: ICTOS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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