Hereditary Angioedema
Conditions
Brief summary
Time-normalized (per 4 weeks) number of Investigator confirmed HAE attacks during the 24 week Treatment Period (Day 1 through Day 168)
Detailed description
Time-normalized number of Investigator confirmed HAE attacks treated with on-demand medication during the 24 week Treatment Period, Time-normalized number of Investigator confirmed moderate or severe HAE attacks during the 24 week Treatment Period, Time-normalized number of Investigator confirmed severe HAE attacks during the 24 week Treatment Period, Proportion of participants achieving ≥50% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants achieving ≥70% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants achieving ≥90% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants that are HAE attack-free during the 24 week Treatment Period, Proportion of time without angioedema symptoms during the 24 week Treatment Period, Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation, Changes in clinical laboratory tests from baseline, Changes in vital signs from baseline, Changes in electrocardiogram (ECG) parameters from baseline, Deucrictibant plasma concentration-time profiles, Angioedema Quality of Life (AE-QoL) questionnaire, Patient Global Assessment of Change (PGA-Change), Angioedema Control Test 4-week version (AECT-4wk), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Interventions
DRUGMatched to test Product Deucrictibant extended release tablets with the exception of active substance
DRUGICATIBANT
Sponsors
Pharvaris Netherlands B.V.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-normalized (per 4 weeks) number of Investigator confirmed HAE attacks during the 24 week Treatment Period (Day 1 through Day 168) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-normalized number of Investigator confirmed HAE attacks treated with on-demand medication during the 24 week Treatment Period, Time-normalized number of Investigator confirmed moderate or severe HAE attacks during the 24 week Treatment Period, Time-normalized number of Investigator confirmed severe HAE attacks during the 24 week Treatment Period, Proportion of participants achieving ≥50% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants achieving ≥70% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants achieving ≥90% reduction in HAE attack rate relative to baseline during the 24 week Treatment Period, Proportion of participants that are HAE attack-free during the 24 week Treatment Period, Proportion of time without angioedema symptoms during the 24 week Treatment Period, Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), ad | — |
Countries
Bulgaria, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Slovakia, Spain
Outcome results
None listed