KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
KVD900 Tablet 150 mg (2 x 75 mg)
KVD900 Tablet 300 mg (1 x 300 mg)
KVD900 Tablet 600 mg (2 x 300 mg)
KalVista Investigative Site
Birmingham, Alabama, United States
The proportion of pediatric patients with HAE Types I or II who take any sebetralstat dose, who experience any AE(s) (including fatal AEs) during the study, irrespective of uses of other medications and sebetralstat discontinuations for any reason.
Time frame: Throughout the duration of the trial, up to 1 year.
Caregiver Global Impression of Change (CaGI-C): Time to beginning of symptom relief defined as at least "a little better" (2 time points in a row)
Time frame: Within 12 hours of the first IMP administration.
Caregiver Global Impression of Severity (CaGI-S): Time to first incidence of decrease from baseline (2 time points in a row)
Time frame: Within 12 hours of the first IMP administration.
CaGI-S: Time to HAE attack resolution defined as "none"
Time frame: Within 24 hours of the first IMP administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
KalVista Investigative Site
Scottsdale, Arizona, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Evansville, Indiana, United States
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Wheaton, Maryland, United States
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St Louis, Missouri, United States
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Toledo, Ohio, United States
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Hershey, Pennsylvania, United States
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Dallas, Texas, United States
...and 14 more locations