Hereditary Angioedema (HAE)
Conditions
Brief summary
Incidence of adverse events, Changes in vital signs, ECG findings, physical examination findings, and clinical laboratory evaluations
Detailed description
Change from baseline in monthly HAE attack rate, Incidence of HAE attack severity (mild, moderate, and severe), Duration of HAE attack (shorter than 12 hours,12 to 24 hours, 24 to 48 hours, and longer than 48 hours), The number of HAE attacks requiring on-demand therapy, Time to first HAE attack after first and last dosing, Concentration of STAR-0215 and the derived PK parameters, Change in plasma kallikrein activity, Formation of anti-drug (STAR-0215) antibodies
Interventions
DRUGSTAR-0215
Sponsors
Astria Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, Changes in vital signs, ECG findings, physical examination findings, and clinical laboratory evaluations | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in monthly HAE attack rate, Incidence of HAE attack severity (mild, moderate, and severe), Duration of HAE attack (shorter than 12 hours,12 to 24 hours, 24 to 48 hours, and longer than 48 hours), The number of HAE attacks requiring on-demand therapy, Time to first HAE attack after first and last dosing, Concentration of STAR-0215 and the derived PK parameters, Change in plasma kallikrein activity, Formation of anti-drug (STAR-0215) antibodies | — |
Countries
Bulgaria, Czechia, Germany, Poland
Outcome results
None listed