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

January 22, 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • 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 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
      • Padua, 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
The proportion of pediatric patients with HAE Types I or II who take any sebetralstat dose, who experience any AE(s) (including fatal AEs) during the study, irrespective of uses of other medications and sebetralstat discontinuations for any reason.
Time Frame: Throughout the duration of the trial, up to 1 year.
Throughout the duration of the trial, up to 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver Global Impression of Change (CaGI-C): Time to beginning of symptom relief defined as at least "a little better" (2 time points in a row)
Time Frame: Within 12 hours of the first IMP administration.
Within 12 hours of the first IMP administration.
Caregiver Global Impression of Severity (CaGI-S): Time to first incidence of decrease from baseline (2 time points in a row)
Time Frame: Within 12 hours of the first IMP administration.
Within 12 hours of the first IMP administration.
CaGI-S: Time to HAE attack resolution defined as "none"
Time Frame: Within 24 hours of the first IMP administration
Within 24 hours of the first IMP administration

Collaborators and Investigators

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

Sponsor

KalVista Pharmaceuticals, Ltd.

Investigators

  • 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)

June 24, 2024

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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