Hereditary Angioedema
Conditions
Brief summary
Incidence of treatment-emergent adverse events
Detailed description
Number of time-normalized investigator-confirmed HAE attacks, Number of moderate or severe investigator-confirmed HAE attacks, Number of investigator-confirmed HAE attacks that require on-demand treatment, Percent reduction in monthly investigator-confirmed HAE attacks, Time to first investigator-confirmed HAE attack after first dose, The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate, Number of participants with no investigator-confirmed HAE attacks, Angioedema Quality of Life (AE-QoL) questionnaire total score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of time-normalized investigator-confirmed HAE attacks, Number of moderate or severe investigator-confirmed HAE attacks, Number of investigator-confirmed HAE attacks that require on-demand treatment, Percent reduction in monthly investigator-confirmed HAE attacks, Time to first investigator-confirmed HAE attack after first dose, The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate, Number of participants with no investigator-confirmed HAE attacks, Angioedema Quality of Life (AE-QoL) questionnaire total score | — |