Hereditary AngioedemaPhase 3NCT05511922
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
A Phase 3 study testing KVD900 600 mg and Drug: KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 61 sites in 17 countries.
Trial summary
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD900 600 mg and Drug: KVD900 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 61 sitesin 17 countries
- Study dates
- 24 Oct 2022to 27 May 2026
- Phase
- Phase 3
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
- Patient is currently participating in KVD900-302.
- Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
- Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.
Who cannot join
- Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.
Trial locations and contacts
61 sites in 17 countries.
61 sites in 17 countries
United States20 sites
KalVista Investigative Site
Centennial, Colorado, 80112
KalVista Investigative Site
Charlotte, North Carolina, 28277
KalVista Investigative Site
Chevy Chase, Maryland, 20815
KalVista Investigative Site
Cincinnati, Ohio, 45236
KalVista Investigative Site
Colorado Springs, Colorado, 80907
KalVista Investigative Site
Dallas, Texas, 75231
KalVista Investigative Site
Evansville, Indiana, 47715
Kalvista Investigative Site
Hershey, Pennsylvania, 17033
KalVista Investigative Site
Layton, Utah, 84041
KalVista Investigative Site
Little Rock, Arkansas, 72205
KalVista Investigative Site
Louisville, Kentucky, 40215
KalVista Investigative Site
Overland Park, Kansas, 66211
KalVista Investigative Site
Plymouth, Minnesota, 55446
KalVista Investigative Site
San Diego, California, 92122
KalVista Investigative Site
San Diego, California, 92123
KalVista Investigative Site
Santa Monica, California, 90404
KalVista Investigative Site
Scottsdale, Arizona, 85251
KalVista Investigative Site
Spokane, Washington, 99204
KalVista Investigative Site
St Louis, Missouri, 63141
KalVista Investigative Site
Toledo, Ohio, 43617
Japan9 sites
KalVista Investigative Site
Chiba, 260-8677
KalVista Investigative Site
Hiroshima, 730-8518
KalVista Investigative Site
Kawagoe-shi, 350-8550
KalVista Investigative Site
Maebashi, 371-8511
KalVista Investigative Site
Sapporo, Hokkaido, 002-8072
KalVista Investigative Site
Soka-shi, 340-0041
KalVista Investigative Site
Takatsuki-shi, 569-8686
KalVista Investigative Site
Tokyo, 142-8666
KalVista Investigative Site
Yokohama, 236-0004
United Kingdom7 sites
KalVista Investigative Site
Birmingham, B9 5SS
KalVista Investigative Site
Cambridge, CB2 0QQ
KalVista Investigative Site
Cardiff, CF14 4XW
KalVista Investgative Site
Frimley, GU16 7UJ
KalVista Investigative Site
Leeds, LS9 7TF
KalVista Investigative Site
London, E1 2ES
KalVista Investigative Site
London, NW3 2QG
Germany4 sites
KalVista Investigative Site
Berlin, 12203
KalVista Investigative Site
Frankfurt, 60590
KalVista Investigative Site
Mainz, 55131
KalVista Investigative Site
Mörfelden-Walldorf, 64546
Israel4 sites
KalVista Investigative Site
Haifa, 31048
KalVista Investigative Site
Petach Tikvah, 4920235
KalVista Investigative Site
Ramat Gan, 52621
KalVista Investigative Site
Tel Aviv, 64239
France3 sites
KalVista Investigative Site
Grenoble, 38043
KalVista Investigative Site
Lille, 59037
KalVista Investigative Site
Paris, 75012
Spain3 sites
KalVista Investigative Site
Barcelona, 08035
KalVista Investigative Site
Barcelona, 08907
KalVista Investigative Site
Madrid, 28046
Greece2 sites
KalVista Investigative Site
Athens, 11521
KalVista Investigative Site
Athens, 11527
About this study
Official title: A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD900 600 mg, Drug: KVD900 300 mg
- Keywords
- KONFIDENT-S, 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.
KVD900 600 mgDrug
KVD900 Tablet 600 mg (2 x 300 mg)
Drug: KVD900 300 mgDrug
KVD900 Tablet 300 mg
| Study group | Role | What they receive |
|---|---|---|
| KVD900 600 mg | Experimental | Not described Receives: Drug: KVD900 600 mg |
| Experimental: KVD900 300 mg | Experimental | Not described Receives: Drug: Drug: KVD900 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Measured: Up to 6 hours after IMP administration
Pharmacokinetics - Tmax
Measured: Up to 6 hours after IMP administration
Pharmacokinetics - AUC
Measured: Up to 6 hours after IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start24 Oct 2022
- Primary completion27 May 2026
- Study completion27 May 2026
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT05511922
- Sponsor's protocol ID
- KVD900-302a
- Status last verified
- May 2026
- First submitted
- 11 Aug 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
- ClinicalTrials.gov ID
- NCT05511922
- Acronym / sponsor ID
- KVD900-302a
- Conditions
- Hereditary Angioedema
- Keywords
- KONFIDENT-S, Sebetralstat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 23 Aug 2022 (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 multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KVD900 600 mg | Experimental | Drug: KVD900 600 mg |
| Experimental: KVD900 300 mg | Experimental | Drug: Drug: KVD900 300 mg |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
- Patient is currently participating in KVD900-302.
- Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
- Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.
Key exclusion criteria (1 listed)
- Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.
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 |
| Drug: KVD900 300 mgKVD900 Tablet 300 mg | Drug | Experimental: KVD900 300 mg |
Primary outcome
Pharmacokinetics - Cmax
Time frame: Up to 6 hours after IMP administration
Pharmacokinetics - Tmax
Time frame: Up to 6 hours after IMP administration
Pharmacokinetics - AUC
Time frame: Up to 6 hours after IMP 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 8 Jun 2026.
- 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.
61 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KVD900 600 mg and Drug: KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 61 sites in 17 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 4 inclusion and 1 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Japan, United Kingdom, Germany, Israel and 12 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?
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?
Pharmacokinetics - Cmax (time frame: Up to 6 hours after IMP administration). The study lists 3 primary outcomes in all. 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 8 Jun 2026.