Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II (KONFIDENT-KID)

August 3, 2026 updated by: KalVista Pharmaceuticals, Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • KalVista Investigative Site
  • France
      • Lille, France, 59000
        • KalVista Investigative Site
      • Marseille, France, 13005
        • KalVista Investigative Site
      • Paris, France, 75012
        • KalVista Investigative Site
  • Germany
      • Frankfurt am Main, Germany, 60590
        • KalVista Investigative Site
      • Frankfurt am Main, Germany, 60596
        • KalVista Investigative Site
  • Israel
      • Haifa, Israel, 31048
        • KalVista Investigative Site
      • Petah Tikva, Israel, 4920235
        • KalVista Investigative Site
      • Tel Aviv, Israel, 6423906
        • KalVista Investigative Site
  • Italy
      • Milan, Italy, 20097
        • KalVista Investigative Site
      • Padova, Italy, 35128
        • KalVista Investigative Site
      • Rome, Italy, 00133
        • KalVista Investigative Site
  • Japan
      • Kawagoe, Japan, 350-8550
        • KalVista Investigative Site
      • Tokyo, Japan, 113-8431
        • KalVista Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • KalVista Investigative Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • KalVista Investigative Site
    • California
      • San Diego, California, United States, 92123
        • KalVista Investigative Site
      • Santa Monica, California, United States, 90404
        • KalVista Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • KalVista Investigative Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • KalVista Investigative Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • KalVista Investigative Site
    • Ohio
      • Toledo, Ohio, United States, 43560
        • KalVista Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17011
        • KalVista Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • KalVista Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients 2 to 11 years of age.
  2. Confirmed diagnosis of HAE Type I or II.
  3. For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
  4. 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.
  5. Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
  6. Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patient weighs <9.5 kg.
  4. Use of angiotensin-converting enzyme inhibitors after the Screening Visit.
  5. 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.
  6. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
  7. 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.
  8. Known hypersensitivity to sebetralstat or to any of the excipients.
  9. Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 300 mg Dose Group
Patients will take a single 300 mg dose of KVD900.
Drug: KVD900 300 mg
KVD900 Tablet 300 mg (1 x 300 mg)
Other: 150 mg Dose Group
Patients will take a single 150 mg dose of KVD900.
Drug: KVD900 150 mg
KVD900 Tablet 150 mg (2 x 75 mg)
Other: 600 mg Dose Group
Patients will take a single 600 mg dose of KVD900.
Drug: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From first dose of IMP until the Final/Early Termination (ET) Visit, up to a maximum of 54 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KalVista Pharmaceuticals, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, KalVista Pharmaceuticals, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KVD900-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared until all global regulatory filings are complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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