drugset / Trial / NCT01188564
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-12
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhC1INH | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | rhC1INH | Protein / enzyme biologic | 4200 iu | Intravenous |