Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00262288 | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | PHASE2 | COMPLETED | 14 | — | — | Apr 1, 2004 | Jan 1, 2007 | Feb 22, 2013 | 1 | Netherlands |
| NCT00261053 | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | PHASE2 | COMPLETED | 14 | — | — | Jun 1, 2003 | Dec 1, 2005 | Apr 25, 2013 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| Recombinant Human C1INH | EXPERIMENTAL | - |
| 1 | OTHER | Open-label i.v. administration of 100 U/kg rhC1INH |
| Name | Type | Description |
|---|---|---|
| i.v. recombinant human C1 inhibitor | DRUG | - |
Main inclusion Criteria: * Clinical and laboratory diagnosis of HAE * Plasma level of functional C1INH of less than 50% of normal * Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: * Acquired angioedema * Pregnancy or breastfeeding ...