Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)

Official title

A Phase 4, Open-Label Trial to Evaluate the Safety and Effectiveness of Sebetralstat When Used as Preprocedural Short-term Prophylaxis in Patients With Hereditary Angioedema

Overview

This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).

Interventions

• Drug KVD900 600 mg
  KVD900 Tablet 600 mg (2 x 300 mg)

Primary outcome measures

• The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized. [Time frame: 24 hours following the start of the procedure]

Eligibility criteria

Inclusion criteria

• Male or female patients ≥12 years of age at time of Screening
• Confirmed diagnosis of HAE Type I or II based on patient report
• Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
• Patient has access to a commercial available on-demand treatment for HAE
• Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
• Patients must be able to swallow trial tablets whole
• 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
• Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• KalVista Investigative Site — Colorado Springs

Identifiers

NCT: NCT07654829 · KVD900-401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗