CompletedPhase 3

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

United States36 participantsStarted 2024-06-24

Plain-language summary

KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.

Who can participate

Age range2 Years – 11 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. 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.
✕. Patient weighs \<9.5 kg.
✕. Use of angiotensin-converting enzyme inhibitors after the Screening Visit.
✕. 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.
✕. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
✕. 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.
✕. Known hypersensitivity to sebetralstat or to any of the excipients.

What they're measuring

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.

Timeframe: Throughout the duration of the trial, up to 1 year.

Trial details

NCT IDNCT06467084

SponsorKalVista Pharmaceuticals, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Hereditary Angioedema trials