Hereditary Angioedema
Conditions
Brief summary
Incidence and severity of treatment-emergent adverse events (TEAEs).
Detailed description
1. The time-normalized number of Investigator-confirmed HAE attacks (per month) from Week 1 to Week 53., 2. The time-normalized number of Investigator-confirmed HAE attacks (per month) from Week 5 to Week 53., 3. The percentage of Investigator-confirmed HAE attack-free patients from Week 5 to Week 53., 4. The time-normalized number of moderate or severe Investigator-confirmed HAE attacks (per month) from Week 5 to Week 53., 5. The number of Investigator-confirmed HAE attacks requiring acute therapy from Week 5 to Week 53., 6. Angioedema Quality of Life (AE-QoL) questionnaire total score over 53 weeks.
Interventions
DRUGISIS 721744
Sponsors
Ionis Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. The time-normalized number of Investigator-confirmed HAE attacks (per month) from Week 1 to Week 53., 2. The time-normalized number of Investigator-confirmed HAE attacks (per month) from Week 5 to Week 53., 3. The percentage of Investigator-confirmed HAE attack-free patients from Week 5 to Week 53., 4. The time-normalized number of moderate or severe Investigator-confirmed HAE attacks (per month) from Week 5 to Week 53., 5. The number of Investigator-confirmed HAE attacks requiring acute therapy from Week 5 to Week 53., 6. Angioedema Quality of Life (AE-QoL) questionnaire total score over 53 weeks. | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs). | — |
Countries
Belgium, Bulgaria, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed