Sebetralstat before procedures for hereditary angioedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, open-label study evaluating the safety and effectiveness of sebetralstat (KVD900) used as short-term prophylaxis before planned procedures in patients with hereditary angioedema. Eligible participants are 12 years and older with Type I or II HAE who have a qualifying procedure within 8 weeks and have access to on-demand HAE treatment. Participants will receive KVD900 600 mg and will be followed to assess safety and the ability to prevent peri-procedural attacks. The study is conducted at KalVista Investigative Site in Colorado Springs, with enrollment managed by KalVista Pharmaceuticals, Ltd. The trial does not indicate a control arm and is designed to collect real-world safety and effectiveness data in this specific use case.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients ≥12 years of age at time of Screening
2. Confirmed diagnosis of HAE Type I or II based on patient report
3. Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
4. Patient has access to a commercial available on-demand treatment for HAE
5. Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
6. Patients must be able to swallow trial tablets whole
7. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire
8. Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
9. Patient provides informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required

Exclusion Criteria:

1. 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
2. Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
3. 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
4. Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
5. 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
6. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
7. Known hypersensitivity to sebetralstat or to any of the excipients
8. Participation in any gene therapy treatment or trial for HAE
9. Any pregnant or breastfeeding patient

Where it's running

• KalVista Investigative Site
  Colorado Springs, Colorado, United States Recruiting

Study contacts

• Study coordinator: KalVista Pharmaceuticals
• Email: clinicalstudies@kalvista.com
• Phone: 1 (857) 999-0075

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• STOP-HAE: ADX-324 for hereditary angioedema

  This trial tests whether ADX-324 can reduce HAE attacks in adults with Type 1 or Type 2 hereditary angioedema.

  Recruiting at 52 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 69 other locations · NCT06960213

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.