An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
Completed · Phase 3
Conditions studied: Hereditary Angioedema
In brief
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
Key facts
- Study ID
- NCT05505916
- Run by
- KalVista Pharmaceuticals, Ltd.
- People needed
- 145
- Starts
- 2022-10-24
- Expected to finish
- 2026-05-27
- Last updated by the study team
- 2026-06-05
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of HAE type I or II at any time in the medical history
- Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit).
- Male or female patients 12 years of age and older.
- Patients must meet the contraception requirements.
- 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 eDiary.
- Investigator believes that the patient is willing and able to adhere to all protocol requirements.
- Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required.
You may not qualify if…
- Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
- Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- A clinically significant history of poor response to bradykinin receptor 2 (BR2) blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
- Use of attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit.
- Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit.
- Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit.
- Inadequate organ function, including but not limited to:
- Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN)
- Aspartate aminotransferase (AST) >2x ULN
- Bilirubin direct >1.25x ULN
- International Normalized Ratio (INR) >1.2
- Clinically significant hepatic impairment defined as a Child-Pugh B or C
- 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 KVD900 or to any of the excipients.
- Participation in any gene therapy treatment or trial for HAE.
- Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to the Enrollment Visit.
- Any pregnant or breastfeeding patient.
Where it is running
- KalVista Investigative Site — Scottsdale, Arizona, United States
- KalVista Investigative Site — Little Rock, Arkansas, United States
- KalVista Investigative Site — Barcelona, Spain
- KalVista Investigative Site — San Diego, California, United States
- KalVista Investigative Site — San Diego, California, United States
- KalVista Investigative Site — Santa Monica, California, United States
- KalVista Investigative Site — Centennial, Colorado, United States
- KalVista Investigative Site — Colorado Springs, Colorado, United States
- KalVista Investigative Site — Evansville, Indiana, United States
- KalVista Investigative Site — Overland Park, Kansas, United States
- KalVista Investigative Site — Louisville, Kentucky, United States
- KalVista Investigative Site — Chevy Chase, Maryland, United States
- KalVista Investigative Site — Plymouth, Minnesota, United States
- KalVista Investigative Site — St Louis, Missouri, United States
- KalVista Investigative Site — Charlotte, North Carolina, United States
- KalVista Investigative Site — Cincinnati, Ohio, United States
- KalVista Investigative Site — Toledo, Ohio, United States
- KalVista Investigative Site — Hershey, Pennsylvania, United States
- KalVista Investigative Site — Dallas, Texas, United States
- KalVista Investgative Site — Layton, Utah, United States
- KalVista Investigative Site — Spokane, Washington, United States
- KalVista Investigative Site — Campbelltown, Australia
- KalVista Investigative Site — Wein, Austria
- KalVista Investigative Site — Sofia, Bulgaria
- KalVista Investigative Site — Barcelona, Spain
Full record on ClinicalTrials.gov
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