drugset / Trial / NCT00811174
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
NaSingle-groupOpen-labelTreatment
Summary
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.
Timeline
- Start
- 2009-01
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 300 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 600 mg/kg | Intravenous |