Hereditary AngioedemaPhase 4NCT07654829
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
A Phase 4 study testing KVD900 600 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United States.
Trial summary
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE). 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?
- KVD900 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 6 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female patients ≥12 years of age at time of Screening
- Confirmed diagnosis of HAE Type I or II based on patient report
- Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
- Patient has access to a commercial available on-demand treatment for HAE
- Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
- Patients must be able to swallow trial tablets whole
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- Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire
- Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
- Patient provides informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required
Who cannot join
- A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator
- Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
- Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit
- Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
- Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial
- History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
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- Known hypersensitivity to sebetralstat or to any of the excipients
- Participation in any gene therapy treatment or trial for HAE
- Any pregnant or breastfeeding patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
KalVista Investigative Site
Colorado Springs, Colorado, 80907
Jennifer Potter, 719-314-0893, jpotter@aacos.com
About this study
Official title: A Phase 4, Open-Label Trial to Evaluate the Safety and Effectiveness of Sebetralstat When Used as Preprocedural Short-term Prophylaxis in Patients With Hereditary Angioedema
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
- Conditions
- Hereditary Angioedema
- Being tested
- KVD900 600 mg
- Keywords
- KVD900
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD900 600 mgDrug
KVD900 Tablet 600 mg (2 x 300 mg)
| Study group | Role | What they receive |
|---|---|---|
| KVD900 600 mg | Experimental | Not described Receives: Drug: KVD900 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized.
Measured: 24 hours following the start of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start17 Aug 2026
- Primary completion29 Nov 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, KalVista Pharmaceuticals, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654829
- Sponsor's protocol ID
- KVD900-401
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label Trial to Evaluate the Safety and Effectiveness of Sebetralstat When Used as Preprocedural Short-term Prophylaxis in Patients With Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT07654829
- Acronym / sponsor ID
- KVD900-401
- Conditions
- Hereditary Angioedema
- Keywords
- KVD900
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (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.
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KVD900 600 mg | Experimental | Drug: KVD900 600 mg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients ≥12 years of age at time of Screening
- Confirmed diagnosis of HAE Type I or II based on patient report
- Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
- Patient has access to a commercial available on-demand treatment for HAE
- Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
Key exclusion criteria (9 listed)
- A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator
- Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
- Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit
- Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
- Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial
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 |
|---|---|---|
| KVD900 600 mgKVD900 Tablet 600 mg (2 x 300 mg) | Drug | KVD900 600 mg |
Primary outcome
The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized.
Time frame: 24 hours following the start of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Study Director study director
KalVista Pharmaceuticals, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KVD900 600 mg in people with 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KalVista Pharmaceuticals (1 (857) 999-0075, clinicalstudies@kalvista.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized. (time frame: 24 hours following the start of the procedure). 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 17 Sep 2026.