Hereditary angioedema
Conditions
Sponsors
Akama Hideto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female >= 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience >= 3 attacks during the 3 months before screening
Exclusion criteria
Exclusion criteria: Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-normalized number of HAE attacks during treatment period (up to 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in the HAE attack rate during the treatment period compared to the run-in period (up to 6 months) 2. Time-normalized number of attacks requiring on-demand treatment (6 months, and first 3 months and second 3 months) 3. Time-normalized number of moderate and/or severe HAE attacks (6 months, and first 3 months and second 3 months) 4. Time-normalized number of HAE attacks at various timepoints during the treatment period (first 3 months and second 3 months and 6 months) 5. Percent reduction in the time-normalized number of HAE attacks between CSL312 and Placebo (6 months, and first 3 months and second 3 months) 6. Subject's Global Assessment of Response to Therapy (SGART) (up to 6 months) 7. Number and percent of subjects with adverse events, adverse events of special interest, serious adverse events, CSL312-induced anti-CSL312 antibodies, clinically significant abnormalities in laboratory assessments (up to 8 months) | — |
Countries
Canada, Germany, Hungary, Israel, Italy, Japan, Netherland, Spain, USA
Contacts
Public ContactHideto Akama
CSL Behring K.K.
Outcome results
None listed