drugset / Trial / NCT01225276
Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP
RandomizedParallel-groupDouble-blindTreatment
Summary
NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Timeline
- Start
- 2011-10
- Primary completion
- 2012-10
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 1 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |