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Indigenous rhG-CSF vs Neupogen in Chemotherapy-Induced Neutropenia
NCT00776165Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2007
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Shantha Biotechnics
- Modality
- Cytokines & Interferons
- Drugs
- filgrastim
- Conditions
- neutropenia
01
Overview
Phase 3, randomised, open-label trial of filgrastim in neutropenia (2 arms), sponsored by Shantha Biotechnics. Primary endpoint: Percentage of patients developing febrile neutropenia. Started Oct 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
rhG-CSF (Shantha)
Indigenous rhG-CSF 300 mcg/day
Neupogen
Neupogen 300 mcg/day
03
Who it enrols
Adult patients with non-myeloid malignancies receiving chemotherapy who experienced neutropenia in a previous cycle.
04
Endpoints
Primary
Percentage of patients developing febrile neutropenia
Secondary
Percentage of patients developing adverse events and/or changes in laboratory values
Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10^9/L not associated with fever
Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia
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