drugset / Trial / NCT01289847
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
NaSingle-groupOpen-labelPrevention
Summary
The main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period. The secondary objectives are to assess the safety and tolerability of Gammaplex and to compare the data collected from adult subjects with PID from the GMX01 study
Timeline
- Start
- 2011-03
- Primary completion
- 2014-04
- Completion
- 2014-04
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 | 800 mg/kg | Intravenous |