drugset / Trial / NCT01079676
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
RandomizedParallel-groupOpen-labelPrevention
Summary
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Timeline
- Start
- 2011-03
- Primary completion
- 2011-04
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |