A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Final cure rate at six months after the end of treatment
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
详细描述
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.
Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates
Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults 2-65 years of age (inclusive) of either gender.
- •Diagnosis of VL confirmed by spleen or bone marrow aspirate.
- •Clinical signs and symptoms compatible with VL.
- •Biochemical and haematological test values as follows:
- •Haemoglobin > 3.5g/100mL
- •White blood cell count > 0.75 x109/L
- •Platelet count > 40 x 109/L
- •AST, ALT and alkaline phosphatase < 5 times upper normal limit
- •Prothrombin time < 4 seconds above control
- •Serum creatinine levels - 1.5 times upper normal limit
- •Serum potassium levels within normal limits
- •HIV negative.
排除标准
- •A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
- •Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- •Proteinuria (> 2+).
- •A history of allergy or hypersensitivity to amphotericin B
- •Previous treatment for VL within two weeks of enrollment into the study.
- •Prior treatment failures with amphotericin B.
研究组 & 干预措施
1
a single dose of 10 mg/kg of liposomal amphotericin B
干预措施: Liposomal Amphotericin B (Drug)
2
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
干预措施: amphotericin B deoxycholate (Drug)
结局指标
主要结局
Final cure rate at six months after the end of treatment
时间窗: One year
次要结局
- Initial cure after the end of treatment(six months)