Hereditary AngioedemaNCT07216378
Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
A study testing Sebetralstat in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 6 sites in United States.
Trial summary
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- Sebetralstat
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 2 to 11 years
- All sexes
- Child
Who may be able to join
- Male or female patients 2 to 11 years of age.
- Parent or LAR provides signed informed consent and patient provides assent (when applicable).
- Confirmed diagnosis of HAE.
Who cannot join
- Confirmed diagnosis of HAE with nC1-INH or acquired angioedema
- Patient weighs <9.5 kg
- Patient participated in the KVD900-303 trial and withdrew prior to trial completion per the protocol or trial closure
- Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
- Known hypersensitivity to sebetralstat or its excipients.
- Patient with a medical history or known to have severe hepatic impairment (Child Pugh C).
- Patients who require sustained use of strong cytochrome P450 3A4 inhibitors or inducers.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
- Available
KalVista Investigative Site
Evansville, Indiana, 47715
- Available
KalVista Investigative Site
Knoxville, Tennessee, 37909
- Available
KalVista Investigative Site
San Antonio, Texas, 78229
- Available
KalVista Investigative Site
San Diego, California, 92123
- Available
KalVista Investigative Site
St Louis, Missouri, 63110
- Available
KalVista Investigative Site
Wheaton, Maryland, 20902
About this study
Official title: On Demand Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With Hereditary Angioedema (HAE) With Sebetralstat
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.
- Conditions
- Hereditary Angioedema
- Being tested
- Sebetralstat
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SebetralstatDrug
Also called KVD900
Oral Plasma Kallikrein Inhibator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216378
- Sponsor's protocol ID
- KVD900-EAP-US-2
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Demand Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With Hereditary Angioedema (HAE) With Sebetralstat
- ClinicalTrials.gov ID
- NCT07216378
- Acronym / sponsor ID
- KVD900-EAP-US-2
- Conditions
- Hereditary Angioedema
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- First posted
- 14 Oct 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.
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.
Study design
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female patients 2 to 11 years of age.
- Parent or LAR provides signed informed consent and patient provides assent (when applicable).
- Confirmed diagnosis of HAE.
Key exclusion criteria (7 listed)
- Confirmed diagnosis of HAE with nC1-INH or acquired angioedema
- Patient weighs <9.5 kg
- Patient participated in the KVD900-303 trial and withdrew prior to trial completion per the protocol or trial closure
- Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
- Known hypersensitivity to sebetralstat or its excipients.
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 |
|---|---|---|
| SebetralstatAlso: KVD900Oral Plasma Kallikrein Inhibator | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sebetralstat in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 6 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KalVista Pharmaceuticals Ltd (1 (857) 999-0075, expandedaccess@kalvista.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 23 Jul 2026.