NL-OMON31209尚未招募2 期
Safety and efficacy of hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients. Part B: Clinical Study Protocol SC13: Safety of a 5 mg dose of hLF1-11 given for 10 consecutive days to autologous haematopoietic stem cell transplant recipients - Safety of hLF1-11 in autologous HSCTrecipients
AM-Pharma0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •· has been admitted for an autologous HSCT after myeloablative therapy with
- •high-dose melphalan;
- •· is being managed with a 3 or 4-lumen central venous catheter;
- •· is at least 18 years old;
- •· has a BMI < 30 kg/M2;
- •· has no medical reason for not participating;
- •· has adequate renal function (creatinine < 1.5 x ULN) ;
- •· has adequate liver function (ASAT, ALAT < 2.5 x ULN, bilirubin < 1.5 x ULN);
- •· if a woman, is functionally post-menopausal;
- •· has not participated in a study of a new chemical molecular entity in the
- •previous 3 months;
- •· is able and willing to participate;
- •· has provided written informed consent.
排除标准
- •Not applicable
研究者
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