drugset / Trial / NCT01918241
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
Phase 2
Unknown
200 enrolled
Hangzhou Jiuyuan Gene Engineering Co. Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabChangsha Central Hospital · collabJiangsu Cancer Institute & Hospital · collabPeking University Cancer Hospital & Institute · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabShandong Cancer Hospital and Institute · collabSubei People's Hospital of Jiangsu Province · collabThe Affiliated Hospital of Inner Mongolia Medical University · collabThe First Affiliated Hospital with Nanjing Medical University · collabWuhan TongJi Hospital · collabYangzhou No.1 People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-01
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 60 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |