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Активно (без набиране) Фаза 3 NCT05505916

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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Hereditary Angioedema

Спонсор: KalVista Pharmaceuticals, Ltd.

Налично на: БГ
Обобщение
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.
Кой може да участва
Patients may roll over from KVD900-301. Inclusion Criteria: 1. Confirmed diagnosis of HAE type I or II at any time in the medical history 2. Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit. 3. 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). 4. Male or female patients 12 years of age and older. 5. Patients must meet the contraception requirements. 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 eDiary. 8. Investigator believes that the patient is willing and able to adhere to all protocol requirements. 9. Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required. Exclusion Criteria: 1. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety. 2. Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator. 3. 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. 4. 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. 5. 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. 6. Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit. 7. 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. 8. Inadequate organ function, including but not limited to: 1. Alanine aminotransferase (ALT) \>2x Upper Limit Normal (ULN) 2. Aspartate aminotransferase (AST) \>2x ULN 3. Bilirubin direct \>1.25x ULN 4. International Normalized Ratio (INR) \>1.2 5. Clinically significant hepatic impairment defined as a Child-Pugh B or C 9. 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. 10. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator. 11. Known hypersensitivity to KVD900 or to any of the excipients. 12. Participation in any gene therapy treatment or trial for HAE. 13. 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. 14. Any pregnant or breastfeeding patient.
Места на провеждане 21
Австралия (1)
KalVista Investigative Site
Campbelltown
България (1)
KalVista Investigative Site
Sofia
Канада (1)
KalVista Investigative Site
Montreal
Франция (1)
KalVista Investigative Site
Grenoble
Германия (1)
KalVista Investigative Site
Berlin
Гърция (1)
KalVista Investigative Site
Athens
Унгария (1)
KalVista Investigative Site
Budapest
Израел (1)
KalVista Investigative Site
Haifa
Италия (1)
KalVista Investigative Site
Padova
Япония (1)
KalVista Investigative Site
Sapporo , Hokkaido
Нидерландия (1)
KalVista Investigative Site
Amsterdam
New Zealand (1)
KalVista Investigative Site
Auckland
North Macedonia (1)
KalVista Investigative Site
Skopje
Полша (1)
KalVista Investigative Site
Krakow
Румъния (1)
KalVista Investigative Site
Sângeorgiu de Mureş
Saudi Arabia (1)
KalVista Investigative Site
Riyadh
Словакия (1)
KalVista Investigative Site
Martin
South Africa (1)
Kalvista Investigative Site
Cape Town
Испания (1)
KalVista Investigative Site
Barcelona
Великобритания (1)
KalVista Investigative Site
Birmingham
САЩ (1)
KalVista Investigative Site
Scottsdale , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
24.10.2022
Крайна дата
30.06.2026
Регистрационен номер
NCT05505916
Източник
anzctr
Запитване за медицински туризъм

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