NCT01919710已完成1 期
Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
Tianjin SinoBiotech Ltd.1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.
详细描述
A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chemotherapy induced neutropenia
排除标准
- •treated with other biological drugs or other neutropenia therapy drugs
研究组 & 干预措施
rHSA/GCSF for injection
Experimental
rHSA/GCSF Start from 300mcg
干预措施: rHSA/GCSF (Drug)
结局指标
主要结局
Number of adverse events
时间窗: 14 days
Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
次要结局
- AUC(14 days)
研究者
研究点 (1)
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