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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KVD900 600 mg | Experimental |
| |
| KVD900 300 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KVD900 600 mg | Drug | KVD900 Tablet 600 mg (2 x 300 mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation. | AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient. | |
| Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit. | Throughout the duration of the trial. | |
| Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit | Throughout the duration of the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGI-C). | time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row) | within 12 hours of initial dose of IMP administration. |
| Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline |
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Patients may roll over from KVD900-301.
Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | KalVista Pharmaceuticals, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KalVista Investigative Site | Scottsdale | Arizona | 85251 | United States | ||
| KalVista Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41252457 | Derived | Bernstein JA, Aygoren-Pursun E, Cancian M, Cohn DM, Craig T, Grivcheva-Panovska V, Jordan A, Lumry WR, Martinez-Saguer I, Melamed I, Ohmura K, Peter J, Riedl MA, Soteres DF, Staubach P, Stobiecki M, Chuang YH, Smith MD, Yea CM, Audhya PK, Zanichelli A, Farkas H. Sebetralstat for On-Demand Treatment of Mucosal Hereditary Angioedema Attacks in KONFIDENT-S. Clin Transl Allergy. 2025 Nov;15(11):e70118. doi: 10.1002/clt2.70118. | |
| 40886933 |
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Data will not be shared until all global regulatory filings are complete.
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| KVD900 300 mg |
| Drug |
KVD900 Tablet 300 mg |
|
| within 12 hours of initial dose of IMP administration. |
| PGI-S: time to HAE attack resolution | PGI-S: time to HAE attack resolution, defines as ''none'' | within 24 hours of initial dose of IMP administration. |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| KalVista Investigative Site | San Diego | California | 92122 | United States |
| KalVista Investigative Site | San Diego | California | 92123 | United States |
| KalVista Investigative Site | Santa Monica | California | 90404 | United States |
| KalVista Investigative Site | Centennial | Colorado | 80112 | United States |
| KalVista Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| KalVista Investigative Site | Evansville | Indiana | 47715 | United States |
| KalVista Investigative Site | Overland Park | Kansas | 66211 | United States |
| KalVista Investigative Site | Louisville | Kentucky | 40215 | United States |
| KalVista Investigative Site | Chevy Chase | Maryland | 20815 | United States |
| KalVista Investigative Site | Plymouth | Minnesota | 55446 | United States |
| KalVista Investigative Site | St Louis | Missouri | 63141 | United States |
| KalVista Investigative Site | Charlotte | North Carolina | 28277 | United States |
| KalVista Investigative Site | Cincinnati | Ohio | 45236 | United States |
| KalVista Investigative Site | Toledo | Ohio | 43617 | United States |
| KalVista Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| KalVista Investigative Site | Dallas | Texas | 75231 | United States |
| KalVista Investgative Site | Layton | Utah | 84041 | United States |
| KalVista Investigative Site | Spokane | Washington | 99204 | United States |
| KalVista Investigative Site | Campbelltown | 2560 | Australia |
| KalVista Investigative Site | Wein | 1090 | Austria |
| KalVista Investigative Site | Sofia | 1431 | Bulgaria |
| KalVista Investigative Site | Montreal | H2W 1R7 | Canada |
| KalVista Investigative Site | Grenoble | 38043 | France |
| KalVista Investigative Site | Lille | 59037 | France |
| KalVista Investigative Site | Paris | 75012 | France |
| KalVista Investigative Site | Berlin | 12203 | Germany |
| KalVista Investigative Site | Frankfurt | 60590 | Germany |
| KalVista Investigative Site | Mainz | 55131 | Germany |
| KalVista Investigative Site | Mörfelden-Walldorf | 64546 | Germany |
| KalVista Investigative Site | Athens | 11521 | Greece |
| KalVista Investigative Site | Athens | 11527 | Greece |
| KalVista Investigative Site | Budapest | 1088 | Hungary |
| KalVista Investigative Site | Haifa | 31048 | Israel |
| KalVista Investigative Site | Petach Tikvah | 4920235 | Israel |
| KalVista Investigative Site | Ramat Gan | 52621 | Israel |
| KalVista Investigative Site | Tel Aviv | 64239 | Israel |
| KalVista Investigative Site | Padova | 35128 | Italy |
| KalVista Investigative Site | Palermo | 90146 | Italy |
| KalVista Investigative Site | Roma | 00133 | Italy |
| KalVista Investigative Site | San Donato Milanese | 20097 | Italy |
| KalVista Investigative Site | Sapporo | Hokkaido | 002-8072 | Japan |
| KalVista Investigative Site | Chiba | 260-8677 | Japan |
| KalVista Investigative Site | Hiroshima | 730-8518 | Japan |
| KalVista Investigative Site | Kawagoe-shi | 350-8550 | Japan |
| KalVista Investigative Site | Maebashi | 371-8511 | Japan |
| KalVista Investigative Site | Soka-shi | 340-0041 | Japan |
| KalVista Investigative Site | Takatsuki-shi | 569-8686 | Japan |
| KalVista Investgative Site | Tokyo | 142-8666 | Japan |
| KalVista Investigative Site | Yokohama | 236-0004 | Japan |
| KalVista Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| KalVista Investigative Site | Auckland | 1023 | New Zealand |
| KalVista Investigative Site | Skopje | 1000 | North Macedonia |
| KalVista Investigative Site | Krakow | 31-503 | Poland |
| KalVista Investigative Site | Lodz | 92-213 | Poland |
| KalVista Investigative Site | Porto | 4200-319 | Portugal |
| KalVista Investigative Site | Sângeorgiu de Mureş | 547530 | Romania |
| KalVista Investigative Site | Riyadh | 11211 | Saudi Arabia |
| KalVista Investigative Site | Martin | 036 59 | Slovakia |
| Kalvista Investigative Site | Cape Town | 7700 | South Africa |
| KalVista Investigative Site | Barcelona | 08035 | Spain |
| KalVista Investigative Site | Barcelona | 08907 | Spain |
| KalVista Investigative Site | Madrid | 28046 | Spain |
| KalVista Investigative Site | Birmingham | B9 5SS | United Kingdom |
| KalVista Investigative Site | Cambridge | CB2 0QQ | United Kingdom |
| KalVista Investigative Site | Cardiff | CF14 4XW | United Kingdom |
| KalVista Investigative Site | Frimley | GU16 7UJ | United Kingdom |
| KalVista Investigative Site | Leeds | LS9 7TF | United Kingdom |
| KalVista Investigative Site | London | E1 2ES | United Kingdom |
| KalVista Investigative Site | London | NW3 2QG | United Kingdom |
| Derived |
| 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 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 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29. |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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| ID | Term |
|---|---|
| C000726128 | sebetralstat |
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