RPCEC00000104已完成4 期
Comparison of two formulations of human recombinant Granulocyte Colony Stimulator Factor (G-CSF) in peripheral blood cells mobilization.
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 个研究点目标入组 35 人开始时间: 2011年4月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 o limit（—）
- 性别
- All
入选标准
- •1.Age major than 18 years old. 2.Informed consent. 3.Patients requiring peripheral blood cells mobilization. 4.ANC within normal limits before inclusion (ANC = 3 x 109/L). 5.Platelet Blood Count within normal limits before inclusion (PBC = 150 x 109/L).
排除标准
- •1.Allergic reaction to GCSF or their ingredients. 2.Malignancies. 3.Chronic or acute liver disease: Bilirrubin >17 micromol/L, SGPT y/o SGOT 1.5 times over their limits, alcalin Fosfatasa 2.5 x upper normal limit (44-147 UI/L). 4.Previous chemotherapy or radiotherapy, 4 weeks before the inclusion. 5.Serious psychiatric disorder or other limitation that contraindicates informed consent or study evaluations. 6.Bone marrow disorder that affect mobilization. 7.Un controlled chronic disease: heard disease, Renal insufficiency, Liver disease, Diabetes Mellitus. 8.Infection that contraindicate some phases of transplant. 9.Young women without effective contraception.
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