NCT00794703已完成3 期
A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 主要终点
- Treatment success rate (fungal breakthrough rate)
研究概览
简要总结
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
详细描述
Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
- •Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
- •Any patient undergoing an allogeneic hematopoietic stem cell transplant
排除标准
- •Patients with moderate or severe liver disease, as defined by:
- •AST or ALT greater than 5 times upper limit of normal (ULN), OR;
- •Total bilirubin greater than 2.5 times ULN
- •Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
研究组 & 干预措施
1. Micafungin
Experimental
干预措施: micafungin (Mycamine) (Drug)
2. Itraconazole
Active Comparator
干预措施: itraconazole (Drug)
结局指标
主要结局
Treatment success rate (fungal breakthrough rate)
时间窗: At the end of the study
次要结局
- Incidence of proven or probable invasive fungal infection(Throughout the study period)
- Time to treatment failure(During the study period)
- The usage rate of systemic antifungal agents(During 4 weeks after the administration)
- Assessment of Adverse events, Laboratory examinations and vital signs evaluation(Throughout the study period)
研究者
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