NCT07239765已完成3 期
An Open-label Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetic Characteristics of Amphotericin B Cholesteryl Sulfate Complex Injection in Patients With Invasive Mold Disease
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
Amphotericin B Cholesteryl Sulfate Complex (ABCD) is a generic drug of amphotericin B colloidal dispersion. This study aimed to explore the safety and efficacy of ABCD in patients with invasive mold disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age;
- •Participant had a diagnosis of proven/probable invasive mold disease (IMD) as determined according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC-MSG) criteria (2019 version) or proven/probable talaromycosis as determined according to diagnostic criteria for endemic mycosis.
排除标准
- •Allergy to amphotericin B or cholesteryl sulfate complex;
- •Mycoses only involved skin above fascia;
- •Expected survival less than 2 months;
- •Pregnant or breast-feeding;
- •Non-negative result on HIV antibody
研究组 & 干预措施
ABCD
Experimental
Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks
干预措施: ABCD (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: Up to 14 weeks
次要结局
- The percentages of the patients who completed the 2 week ABCD therapeutic regimen(Up to 12 weeks)
- The percentages of the patients who completed the 4 week ABCD therapeutic regimen(Up to 12 weeks)
- The percentages of the patients who completed the 6 week ABCD therapeutic regimen(Up to 12 weeks)
- The proportion of patients achieving the clinical response of complete remission (CR), partial remission (PR) or stable disease (SD)(Up to 12 weeks)
- The proportion of patients achieving the clinical response of CR or PR(Up to 12 weeks)
- The proportion of patients with a microbiological response of eradication or presumed eradication(Up to 12 weeks)
研究者
研究点 (1)
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