KCT0000518已完成未知
Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy
Dong-A Pharm0 个研究点目标入组 74 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •(1)Age : =18, =70
- •(2)Diagnosis of stage II, III or IV breast cancer
- •(3)ANC=1,500/mm3, Platelet=100,000/mm3, ECOG : 0 or 1
- •(4)Creatinine < 1.5 x ULN
- •(5)Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN
- •(6)Have given a written, informed consent
排除标准
- •(1)Prior chemotherapy
- •(2)Prior bone marrow or stem cell transplantation
- •(3)Other malignancy history within 5 years
- •(4)Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
- •(5)Received any other investigational drugs within 30 days of informed consent date
- •(6)Radiation therapy within 4 weeks of informed consent date
- •(7)Infective symptom before chemotherapy into this study
- •(8)Received systemic antibiotics within 72 hours of randomization into this study.
- •(9)HIV positive
- •(10)Pregnant or lactating women
- •(11)Other case at investigator's discretion
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