A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months
研究概览
简要总结
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
详细描述
Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious, chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis, has a mortality rate of nearly 100%.
The goal of the project is to establish that a single dose of AMPHOMUL® can be used to achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more affordable than current treatment, and is without the risk of drug resistance.
The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either treatment naive or treatment resistant to other antileishmanial drugs.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 5 to 65 years (both inclusive).
- •Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
- •Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by rK39 dipstick test with confirmation by splenic or bone marrow aspirate smear examination.
- •Non-pregnant, non-lactating females of age ≥5 years, and woman of childbearing potential who are willing to use acceptable methods of contraception
- •Negative Urine pregnancy test (UPT) in all women
排除标准
- •Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
- •Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
- •Concurrent diabetes, tuberculosis or bacterial pneumonia or any other infectious or major psychiatric disease.
- •Pregnant or nursing women
- •Patients receiving any of the medications prohibited by the study protocol.
- •Simultaneous participation in another trial or received any IP <30 days prior to enrolment.
研究组 & 干预措施
Amphotericin B lipid emulsion
Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion
干预措施: Amphotericin B Lipid emulsion (Drug)
Liposomal Amphotericin B
Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B
干预措施: Liposomal Amphotericin B (Drug)
结局指标
主要结局
Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months
时间窗: Six months after dose administration
次要结局
- To assess the Number of AEs, SAEs, Incidence of IRTs, with no Incidence of nephrotoxicity and hepatotoxicity and no change in the Laboratory values for different parameters(within 30 to 45 days from drug administration and continue throughout duration of study)