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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified December 2025 by KalVista Pharmaceuticals, Ltd.
Sponsor
KalVista Pharmaceuticals, Ltd.
Information Provided by (Responsible Party)
KalVista Pharmaceuticals, Ltd.
Clinicaltrials.gov Identifier
NCT06467084
Other Study ID Numbers:
KVD900-303
First Submitted
June 13, 2024
First Posted
June 19, 2024
Last Update Posted
January 22, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hereditary Angioedema
Drug: KVD900 150 mgDrug: KVD900 300 mgDrug: KVD900 600 mg

Study Design

Study TypeInterventional
Actual Enrollment36 participants
Design AllocationNon-Randomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleOpen-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II
Study Start DateJune 23, 2024
Actual Primary Completion DateJanuary 14, 2026
Actual Study Completion DateJanuary 14, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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)
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)
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)

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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)
  2. Caregiver Global Impression of Severity (CaGI-S): Time to first incidence of decrease from baseline (2 time points in a row)
  3. CaGI-S: Time to HAE attack resolution defined as "none"

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsKalVista Pharmaceuticals, Ltd.
Locations
KalVista Investigative Site | Birmingham Alabama, United States, 35209KalVista Investigative Site | Scottsdale Arizona, United States, 85251KalVista Investigative Site | San Diego California, United States, 92123KalVista Investigative Site | Santa Monica California, United States, 90404KalVista Investigative Site | Evansville Indiana, United States, 47715KalVista Investigative Site | Wheaton Maryland, United States, 20902KalVista Investigative Site | St Louis Missouri, United States, 63141KalVista Investigative Site | Toledo Ohio, United States, 43560KalVista Investigative Site | Hershey Pennsylvania, United States, 17011KalVista Investigative Site | Dallas Texas, United States, 75231KalVista Investigative Site | Edmonton Alberta, Canada, T6G 2B7KalVista Investigative Site | Lille , France, 59000KalVista Investigative Site | Marseille , France, 13005KalVista Investigative Site | Paris , France, 75012KalVista Investigative Site | Frankfurt am Main , Germany, 60590KalVista Investigative Site | Frankfurt am Main , Germany, 60596KalVista Investigative Site | Haifa , Israel, 31048KalVista Investigative Site | Petah Tikva , Israel, 4920235KalVista Investigative Site | Tel Aviv , Israel, 6423906KalVista Investigative Site | Milan , Italy, 20097KalVista Investigative Site | Padova , Italy, 35128KalVista Investigative Site | Rome , Italy, 00133KalVista Investigative Site | Kawagoe , Japan, 350-8550KalVista Investigative Site | Tokyo , Japan, 113-8431
Investigators
Study Director: Study Director, KalVista Pharmaceuticals, Ltd.