Hereditary Angioedema Type I or II
Conditions
Brief summary
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.
Detailed description
CaGI-C: Time to beginning of symptom relief defined as at least “a little better” (2 time points in a row) within 12 hours of the first IMP administration., CaGI-S: Time to first incidence of decrease from baseline (2 time points in a row) within 12 hours of the first IMP administration., CaGI-S: Time to HAE attack resolution defined as “none” within 24 hours of the first IMP Administration, Time to use of conventional on-demand treatment within 12 hours of the first IMP administration.
Interventions
DRUGKVD900
Sponsors
Kalvista Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| CaGI-C: Time to beginning of symptom relief defined as at least “a little better” (2 time points in a row) within 12 hours of the first IMP administration., CaGI-S: Time to first incidence of decrease from baseline (2 time points in a row) within 12 hours of the first IMP administration., CaGI-S: Time to HAE attack resolution defined as “none” within 24 hours of the first IMP Administration, Time to use of conventional on-demand treatment within 12 hours of the first IMP administration. | — |
Countries
France, Germany, Italy
Outcome results
None listed