NCT07654829 · KalVista Pharmaceuticals, Ltd.
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
What this study is about
This is a Phase 4, forward-looking, where both patients and doctors know the treatment given 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).
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Colorado Springs, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations