Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
NCT ID: NCT06467084
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2024-06-24
2026-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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150 mg Dose Group
Patients will take a single 150 mg dose of KVD900.
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.
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.
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Interventions
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KVD900 150 mg
KVD900 Tablet 150 mg (2 x 75 mg)
KVD900 300 mg
KVD900 Tablet 300 mg (1 x 300 mg)
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
11 Years
ALL
No
Sponsors
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KalVista Pharmaceuticals, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
KalVista Pharmaceuticals, Ltd.
Locations
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KalVista Investigative Site
Birmingham, Alabama, United States
KalVista Investigative Site
Scottsdale, Arizona, United States
KalVista Investigative Site
San Diego, California, United States
KalVista Investigative Site
Santa Monica, California, United States
KalVista Investigative Site
Evansville, Indiana, United States
KalVista Investigative Site
Wheaton, Maryland, United States
KalVista Investigative Site
St Louis, Missouri, United States
KalVista Investigative Site
Toledo, Ohio, United States
KalVista Investigative Site
Hershey, Pennsylvania, United States
KalVista Investigative Site
Dallas, Texas, United States
KalVista Investigative Site
Edmonton, Alberta, Canada
KalVista Investigative Site
Lille, , France
KalVista Investigative Site
Marseille, , France
KalVista Investigative Site
Paris, , France
KalVista Investigative Site
Frankfurt am Main, , Germany
KalVista Investigative Site
Frankfurt am Main, , Germany
KalVista Investigative Site
Haifa, , Israel
KalVista Investigative Site
Petah Tikva, , Israel
KalVista Investigative Site
Tel Aviv, , Israel
KalVista Investigative Site
Milan, , Italy
KalVista Investigative Site
Padua, , Italy
KalVista Investigative Site
Rome, , Italy
KalVista Investigative Site
Kawagoe, , Japan
KalVista Investigative Site
Tokyo, , Japan
Countries
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Other Identifiers
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KVD900-303
Identifier Type: -
Identifier Source: org_study_id
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