drugset / Trial / NCT00914966
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
NaSingle-groupOpen-labelPrevention
Summary
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3. To assess the immunogenicity of CINRYZE.
Timeline
- Start
- 2009-08-31
- Primary completion
- 2012-05-24
- Completion
- 2012-05-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CINRYZE | Protein / enzyme biologic | 1500 iu | Intravenous |
| Subject | CINRYZE | Protein / enzyme biologic | 2000 iu | Intravenous |
| Subject | CINRYZE | Protein / enzyme biologic | 2500 iu | Intravenous |