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Safety and effectiveness of KVD900 in children with hereditary angioedema

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

Phase 3 Interventional KalVista Pharmaceuticals, Ltd. · NCT06467084

This study is testing how safe and effective a new medication called KVD900 is for children aged 2 to 11 with hereditary angioedema to see if it helps manage their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment36 (estimated)
Ages2 Years to 11 Years
SexAll
SponsorKalVista Pharmaceuticals, Ltd. Industry-sponsored
Locations23 sites (Birmingham, Alabama and 22 other locations)
Trial IDNCT06467084 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, pharmacokinetics, and efficacy of KVD900 in pediatric patients aged 2 to 11 years diagnosed with Hereditary Angioedema (HAE) Type I or II. It is an open-label, multicenter study where participants will receive varying doses of KVD900 (75 mg, 150 mg, or 300 mg) to assess its impact on managing HAE symptoms. The trial aims to determine how well the medication works and its safety profile in this young population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 2 to 11 years with a confirmed diagnosis of HAE Type I or II who have experienced at least one HAE attack in the past year.

Not a fit: Patients with other forms of chronic angioedema or those who have had poor responses to existing treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for children suffering from hereditary angioedema, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating hereditary angioedema with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaKONFIDENT-KID
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.