Hereditary AngioedemaPhase 3KONFIDENT-KIDNCT06467084
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
A Phase 3 study testing KVD900 150 mg, KVD900 300 mg and KVD900 600 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 24 sites in 7 countries.
Trial summary
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II. 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?
- KVD900 150 mg, KVD900 300 mg and KVD900 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 1 Aug 2024to 15 Jan 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients 2 to 11 years of age.
- Confirmed diagnosis of HAE Type I or II.
- For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
- Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
- Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
- Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).
Who cannot join
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria.
- 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.
- Patient weighs <9.5 kg.
- Use of angiotensin-converting enzyme inhibitors after 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 require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
Show all 9Show fewer
- 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.
- Known hypersensitivity to sebetralstat or to any of the excipients.
- Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States10 sites
KalVista Investigative Site
Birmingham, Alabama, 35209
KalVista Investigative Site
Dallas, Texas, 75231
KalVista Investigative Site
Evansville, Indiana, 47715
KalVista Investigative Site
Hershey, Pennsylvania, 17011
KalVista Investigative Site
San Diego, California, 92123
KalVista Investigative Site
Santa Monica, California, 90404
KalVista Investigative Site
Scottsdale, Arizona, 85251
KalVista Investigative Site
St Louis, Missouri, 63141
KalVista Investigative Site
Toledo, Ohio, 43560
KalVista Investigative Site
Wheaton, Maryland, 20902
France3 sites
KalVista Investigative Site
Lille, 59000
KalVista Investigative Site
Marseille, 13005
KalVista Investigative Site
Paris, 75012
Israel3 sites
KalVista Investigative Site
Haifa, 31048
KalVista Investigative Site
Petah Tikva, 4920235
KalVista Investigative Site
Tel Aviv, 6423906
Italy3 sites
KalVista Investigative Site
Milan, 20097
KalVista Investigative Site
Padova, 35128
KalVista Investigative Site
Rome, 00133
Germany2 sites
KalVista Investigative Site
Frankfurt am Main, 60590
KalVista Investigative Site
Frankfurt am Main, 60596
Japan2 sites
KalVista Investigative Site
Kawagoe, 350-8550
KalVista Investigative Site
Tokyo, 113-8431
About this study
Official title: Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Keywords
- KONFIDENT-KID
- 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 150 mgDrug
KVD900 Tablet 150 mg (2 x 75 mg)
KVD900 300 mgDrug
KVD900 Tablet 300 mg (1 x 300 mg)
KVD900 600 mgDrug
KVD900 Tablet 600 mg (2 x 300 mg)
| Study group | Role | What they receive |
|---|---|---|
| 150 mg Dose Group | Other | Patients will take a single 150 mg dose of KVD900. Receives: Drug: KVD900 150 mg |
| 300 mg Dose Group | Other | Patients will take a single 300 mg dose of KVD900. Receives: Drug: KVD900 300 mg |
| 600 mg Dose Group | Other | Patients will take a single 600 mg dose of KVD900. Receives: Drug: KVD900 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that met any of the following conditions: (1) began on or after the first dose of IMP, (2) began before the first dose of IMP and increased in severity on or after first dose, (3) was completely missing a start date and the stop date, (4) was completely missing a start date and the stop date was on or after the first dose of IMP. An on-treatment TEAE was defined as any TEAE occurring within 3 days of IMP administration. A treatment-related TEAE was an AE considered related to the IMP by the investigator. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation, resulted in significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event (based upon medical and scientific judgment).
Measured: From first dose of IMP until the Final/Early Termination (ET) Visit, up to a maximum of 54 weeks.
Secondary outcomes (1)
Plasma Concentrations of Sebetralstat
During the Enrollment Visit, participants were dosed with IMP (sebetralstat 300 mg ED) and monitored for tolerability. Pharmacokinetic (PK) samples were collected via venous access or capillary collection (eg, finger prick) at specified timepoints. For participants enrolled under protocol v3.4 who received sebetralstat 600 mg ED, a second PK assessment was performed at the Dose Increase Visit. The Dose Increase Visit occurred as soon as possible after implementation of the protocol amendment and could occur at any time during the participant's participation in the trial.
Measured: At 0.5 hours (±5 min), 2 hours (±15 min), and 4 hours (±15 min) post-dose. PK assessments for sebetralstat 300 mg ED were conducted at the Enrollment Visit, and for 600 mg ED at the Dose Increase Visit (up to 12.6 months after Enrollment Visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Aug 2024
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT06467084
- Sponsor's protocol ID
- KVD900-303
- Acronym
- KONFIDENT-KID
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2024
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared until all global regulatory filings are complete.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II
- ClinicalTrials.gov ID
- NCT06467084
- Acronym / sponsor ID
- KONFIDENT-KID / KVD900-303
- Conditions
- Hereditary Angioedema
- Keywords
- KONFIDENT-KID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 mg Dose Group | Other | Drug: KVD900 150 mgPatients will take a single 150 mg dose of KVD900. |
| 300 mg Dose Group | Other | Drug: KVD900 300 mgPatients will take a single 300 mg dose of KVD900. |
| 600 mg Dose Group | Other | Drug: KVD900 600 mgPatients will take a single 600 mg dose of KVD900. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female patients 2 to 11 years of age.
- Confirmed diagnosis of HAE Type I or II.
- For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
- Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
- Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
Key exclusion criteria (9 listed)
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria.
- 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.
- Patient weighs <9.5 kg.
- Use of angiotensin-converting enzyme inhibitors after 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.
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 150 mgKVD900 Tablet 150 mg (2 x 75 mg) | Drug | 150 mg Dose Group |
| KVD900 300 mgKVD900 Tablet 300 mg (1 x 300 mg) | Drug | 300 mg Dose Group |
| KVD900 600 mgKVD900 Tablet 600 mg (2 x 300 mg) | Drug | 600 mg Dose Group |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of IMP until the Final/Early Termination (ET) Visit, up to a maximum of 54 weeks.
A TEAE was defined as an adverse event (AE) that met any of the following conditions: (1) began on or after the first dose of IMP, (2) began before the first dose of IMP and increased in severity on or after first dose, (3) was completely missing a start date and the stop date, (4) was completely missing a start date and the stop date was on or after the first dose of IMP. An on-treatment TEAE was defined as any TEAE occurring within 3 days of IMP administration. A treatment-related TEAE was an AE considered related to the IMP by the investigator. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation, resulted in significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event (based upon medical and scientific judgment).
1 secondary outcome
Plasma Concentrations of Sebetralstat
Time frame: At 0.5 hours (±5 min), 2 hours (±15 min), and 4 hours (±15 min) post-dose. PK assessments for sebetralstat 300 mg ED were conducted at the Enrollment Visit, and for 600 mg ED at the Dose Increase Visit (up to 12.6 months after Enrollment Visit).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared until all global regulatory filings are complete.
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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.
Study Director study director
KalVista Pharmaceuticals, Ltd.
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KVD900 150 mg, KVD900 300 mg and KVD900 600 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 24 sites in 7 countries.
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 6 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, Israel, Italy, Germany and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of IMP until the Final/Early Termination (ET) Visit, up to a maximum of 54 weeks.). 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 5 Aug 2026.