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)
NCT ID: NCT05505916
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
145 participants
INTERVENTIONAL
2022-10-24
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KVD900 600 mg
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 300 mg
KVD900 300 mg
KVD900 Tablet 300 mg
Interventions
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KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 300 mg
KVD900 Tablet 300 mg
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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KalVista Pharmaceuticals, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
KalVista Pharmaceuticals, Ltd.
Locations
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KalVista Investigative Site
Scottsdale, Arizona, United States
KalVista Investigative Site
Little Rock, Arkansas, United States
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
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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
Montreal, , Canada
KalVista Investigative Site
Grenoble, , France
KalVista Investigative Site
Lille, , France
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Paris, , France
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Berlin, , Germany
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Frankfurt, , Germany
KalVista Investigative Site
Mainz, , Germany
KalVista Investigative Site
Mörfelden-Walldorf, , Germany
KalVista Investigative Site
Athens, , Greece
KalVista Investigative Site
Athens, , Greece
KalVista Investigative Site
Budapest, , Hungary
KalVista Investigative Site
Haifa, , Israel
KalVista Investigative Site
Petach Tikvah, , Israel
KalVista Investigative Site
Ramat Gan, , Israel
KalVista Investigative Site
Tel Aviv, , Israel
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Padua, , Italy
KalVista Investigative Site
Palermo, , Italy
KalVista Investigative Site
Roma, , Italy
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San Donato Milanese, , Italy
KalVista Investigative Site
Sapporo, Hokkaido, Japan
KalVista Investigative Site
Chiba, , Japan
KalVista Investigative Site
Hiroshima, , Japan
KalVista Investigative Site
Kawagoe-shi, , Japan
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Maebashi, , Japan
KalVista Investigative Site
Soka-shi, , Japan
KalVista Investigative Site
Takatsuki-shi, , Japan
KalVista Investgative Site
Tokyo, , Japan
KalVista Investigative Site
Yokohama, , Japan
KalVista Investigative Site
Amsterdam, , Netherlands
KalVista Investigative Site
Auckland, , New Zealand
KalVista Investigative Site
Skopje, , North Macedonia
KalVista Investigative Site
Krakow, , Poland
KalVista Investigative Site
Lodz, , Poland
KalVista Investigative Site
Porto, , Portugal
KalVista Investigative Site
Sângeorgiu de Mureş, , Romania
KalVista Investigative Site
Riyadh, , Saudi Arabia
KalVista Investigative Site
Martin, , Slovakia
Kalvista Investigative Site
Cape Town, , South Africa
KalVista Investigative Site
Barcelona, , Spain
KalVista Investigative Site
Barcelona, , Spain
KalVista Investigative Site
Madrid, , Spain
KalVista Investigative Site
Birmingham, , United Kingdom
KalVista Investigative Site
Cambridge, , United Kingdom
KalVista Investigative Site
Cardiff, , United Kingdom
KalVista Investigative Site
Frimley, , United Kingdom
KalVista Investigative Site
Leeds, , United Kingdom
KalVista Investigative Site
London, , United Kingdom
KalVista Investigative Site
London, , United Kingdom
Countries
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References
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Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach-Renz P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Aug 29:S2213-2198(25)00821-9. doi: 10.1016/j.jaip.2025.08.020. Online ahead of print.
Other Identifiers
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KVD900-302
Identifier Type: -
Identifier Source: org_study_id