This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Placebo to KVD900 Tablet
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 Tablet 300 mg (1 x 300 mg)
Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C)
The analysis of time to the beginning of symptom relief defined as at least "a little better" (2 time points in a row) on the PGI-C within 12 hours of the first IMP administration using the Gehan score transformation test for Full Analysis Set (FAS). Attacks were treated as right-censored at 12 hours if they did not achieve beginning of symptom relief defined by PGI-C as at least "a little better" (2 time points in a row) or received conventional attack treatment prior to time-to-event within 12 hours of the first IMP administration. When an endpoint result was non-evaluable (NE) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: Within 12 hours of the first investigational medicinal product (IMP) administration.
Time to First Incidence of Decrease From Baseline Patient Global Impression of Severity (PGI-S) (2 Time Points in a Row)
First incidence of decrease in attack severity at two time points in a row (with possible missing values in between) within 12 hours of the first IMP administration. Attacks were treated as right-censored at 12 hours if they did not have a decrease in PGI-S score from baseline for 2 time points in a row or received conventional attack treatment prior to time-to-event within 12 hours of the first IMP administration. When an endpoint result was non-evaluable (NE) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: Within 12 hours of the first IMP administration.
Time to Complete HAE Attack Resolution (PGI-S)
Time to complete HAE attack resolution defined as "none". Attacks were treated as right-censored at 24 hours if they did reach complete HAE attack resolution or received conventional attack treatment prior to time-to-event within 24 hours of IMP administration. When an endpoint result was non-evaluable (NE) within 24 hours, if the event did occur, the event must have occurred \>24 hours following study drug.
Time frame: Within 24 hours of the first IMP administration.
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KalVista Investigative Site
Birmingham, Alabama, United States
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
Tampa, Florida, United States
KalVista Investigative Site
Chicago, Illinois, United States
...and 56 more locations