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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505916
Other study ID # KVD900-302
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 24, 2022
Est. completion date January 30, 2026

Study information

Verified date March 2024
Source KalVista Pharmaceuticals, Ltd.
Contact KalVista Pharmaceuticals
Phone 1 (857) 999-0075
Email clinicalstudies@kalvista.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 30, 2026
Est. primary completion date January 30, 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)

Locations

Country Name City State
Australia KalVista Investigative Site Campbelltown
Austria KalVista Investigative Site Wein
Bulgaria KalVista Investigative Site Sofia
Canada KalVista Investigative Site Montréal
France KalVista Investigative Site Grenoble Cedex 9
France KalVista Investigative Site Lille
France KalVista Investigative Site Lille Cedex
France KalVista Investigative Site Paris
Germany KalVista Investigative Site Berlin
Germany KalVista Investigative Site Frankfurt
Germany KalVista Investigative Site Mainz
Germany KalVista Investigative Site Morfelden-Walldorf
Greece KalVista Investigative Site Athens
Greece KalVista Investigative Site Athens
Hungary KalVista Investigative Site Budapest
Israel KalVista Investigative Site Haifa
Israel KalVista Investigative Site Petach Tikvah
Israel KalVista Investigative Site Ramat Gan
Israel KalVista Investigative Site Tel Aviv
Italy KalVista Investigative Site Padova
Italy KalVista Investigative Site Palermo
Italy KalVista Investigative Site Roma
Italy KalVista Investigative Site San Donato Milanese
Japan KalVista Investigative Site Chiba-shi
Japan KalVista Investigative Site Hiroshima-shi
Japan KalVista Investigative Site Kawagoe-shi
Japan KalVista Investigative Site Maebashi-city
Japan KalVista Investigative Site Sapporo-city Hokkaido
Japan KalVista Investigative Site Soka-shi
Japan KalVista Investigative Site Takatsuki-shi
Japan KalVista Investgative Site Tokyo
Japan KalVista Investigative Site Yokohama-shi
Netherlands KalVista Investigative Site Amsterdam
New Zealand KalVista Investigative Site Auckland
North Macedonia KalVista Investigative Site Skopje
Poland KalVista Investigative Site Kraków
Poland KalVista Investigative Site Lódz
Portugal KalVista Investigative Site Porto
Romania KalVista Investigative Site Sângeorgiu De Mures
Saudi Arabia KalVista Investigative Site Riyadh
Slovakia KalVista Investigative Site Martin
South Africa Kalvista Investigative Site Cape Town
Spain KalVista Investigative Site Barcelona
Spain KalVista Investigative Site Barcelona
Spain KalVista Investigative Site Madrid
United Kingdom 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 States KalVista Investigative Site Centennial Colorado
United States KalVista Investigative Site Charlotte North Carolina
United States KalVista Investigative Site Chevy Chase Maryland
United States KalVista Investigative Site Cincinnati Ohio
United States KalVista Investigative Site Colorado Springs Colorado
United States KalVista Investigative Site Dallas Texas
United States KalVista Investigative Site Evansville Indiana
United States KalVista Investigative Site Hershey Pennsylvania
United States KalVista Investgative Site Layton Utah
United States KalVista Investigative Site Little Rock Arkansas
United States KalVista Investigative Site Louisville Kentucky
United States KalVista Investigative Site Overland Park Kansas
United States KalVista Investigative Site Plymouth Minnesota
United States KalVista Investigative Site Saint Louis Missouri
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 Scottsdale Arizona
United States KalVista Investigative Site Spokane Washington
United States KalVista Investigative Site Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
KalVista Pharmaceuticals, Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  New Zealand,  North Macedonia,  Poland,  Portugal,  Romania,  Saudi Arabia,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit. Throughout the duration of the trial.
Primary Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit Throughout the duration of the trial.
Secondary 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.
Secondary Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline within 12 hours of initial dose of IMP administration.
Secondary 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.
See also
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