Hereditary AngioedemaICTOSNCT07009262
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
An observational study of Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- Inapplicable
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a self-reported diagnosis of HAE Type I or II who take icatibant to treat HAE attacks
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
KalVista Investigative Site
Fairfax, Virginia, 22030
About this study
Official title: A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of 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.
- Conditions
- Hereditary Angioedema
- Being tested
- Inapplicable
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InapplicableOther
Inapplicable
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks. | Not described Receives: Other: Inapplicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change (PGI-C)
time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row)
Measured: Within 12 hours of the first Icatibant dose adminstration
Secondary outcomes (4)
Patient Global Impression of Severity (PGI-S)
Time to first incidence of decrease from baseline (2 time points in a row)
Measured: Within 12 hours of the first Icatibant dose adminstration
PGI-S: Time to Complete HAE Attack Resolution
time to HAE attack resolution, defined as ''none''
Measured: Within 24 hours of the first Icatibant dose adminstration
Return to normal function
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
Measured: At 48 hours after first Icatibant dose adminstration
General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS
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
Measured: over 12 and 24 hours of the first icatibant administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start21 Apr 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Hereditary Angioedema Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009262
- Sponsor's protocol ID
- ICTOS-001
- Acronym
- ICTOS
- Status last verified
- Jan 2026
- First submitted
- 7 May 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing but only after deidentification of individual patient data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks
- ClinicalTrials.gov ID
- NCT07009262
- Acronym / sponsor ID
- ICTOS / ICTOS-001
- Conditions
- Hereditary Angioedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- US Hereditary Angioedema Association
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks. | – | Other: Inapplicable |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a self-reported diagnosis of HAE Type I or II who take icatibant to treat HAE attacks
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InapplicableInapplicable | Other | Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks. |
Primary outcome
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)
4 secondary outcomes
Patient Global Impression of Severity (PGI-S)
Time frame: Within 12 hours of the first Icatibant dose adminstration
PGI-S: Time to Complete HAE Attack Resolution
Time frame: Within 24 hours of the first Icatibant dose adminstration
Return to normal function
Time frame: At 48 hours after first Icatibant dose adminstration
General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS
Time frame: over 12 and 24 hours of the first icatibant administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing but only after deidentification of individual patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (PGI-C) (time frame: Within 12 hours of the first Icatibant dose adminstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.