A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Dose limiting toxicities according to specified criteria
研究概览
简要总结
The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation.
The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
- •Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
- •Presence of fever defined as > 38°C tympanic temperature or a history of fever within the last 24 hours
排除标准
- •Mixed infection with other Plasmodium species
- •Any criteria of severe or complicated malaria as defined by the WHO, 2010
- •Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
- •Presence of significant anemia as defined by Hb <8 g/dL or Hct < 25%
- •A platelet count < 50,000/μL
- •Presence of febrile conditions caused by diseases other than malaria
研究组 & 干预措施
Sevuparin/DF02
Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
干预措施: Sevuparin sodium + atovaquone/proquanil (Drug)
Control
Anti-malarial regimen (Malanil®) alone
干预措施: atovaquone/proquanil (Drug)
结局指标
主要结局
Dose limiting toxicities according to specified criteria
时间窗: During treatment and 14 days post treatment follow-up.
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
时间窗: 72 hours
次要结局
未报告次要终点