This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
KalVista Investigative Site
Scottsdale, Arizona, United States
Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set)
The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Proportion of HAE Attacks That Worsen in Severity by One Level or More on the PGI-S or Require Conventional Attack Treatment Within 12 Hours of Study Drug (Full Analysis Set)
The proportion of participant's HAE attacks to either worsen in attack severity on the PGI-S by one level or more or conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) use are listed with censored observations flagged. Frequencies (n, %) of subjects experiencing a worsening on the PGI-S by one level or more or using conventional attack treatment and the number censored are presented. "Y" Row indicates "participants who experienced a worsening in severity, and the "N" Row indicates participants who did not.
Time frame: 12 hours
Time to Either Worsening in HAE Attack Severity by One Level or More on the PGI-S or to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set)
HAE attack severity assessed using the Patient Global Impression of Severity scale (PGI-S). Censoring occurs where a subject did not worsen in severity or use conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Time to Symptom Relief Defined as HAE Attack Rated as "A Little Better" or Higher on the PGI-C for Two Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set)
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KalVista Investigative Site
Centennial, Colorado, United States
KalVista Investigative Site
Chevy Chase, Maryland, United States
KalVista Investigative Site
Cincinnati, Ohio, United States
KalVista Investigative Site
Dallas, Texas, United States
KalVista Investigative Site
Spokane, Washington, United States
KalVista Investigative Site
Vienna, Austria
KalVista Investigative Site
Brno, Czechia
KalVista Investigative Site
Hradec Králové, Czechia
KalVista Investigative Site
Pilsen, Czechia
...and 15 more locations
Change in HAE attack severity assessed using the Patient Global Impression of Change 7-point transition question (PGI-C). Censoring occurs where an attack rating of "a little better" or higher for two consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Time to Symptom Relief Defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set)
The HAE attack symptoms were assessed on a 100 mm visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe). The Composite VAS score is defined as the mean score across all symptoms. Censoring occurs where a ≥50% reduction in Composite VAS Score for three consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur the event must have occurred \>12 hours following study drug.
Time frame: 12 hours