NCT01755403已完成4 期
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
Barcelona Centre for International Health Research1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Population pharmacokinetic parameters of Benznidazole
研究概览
简要总结
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
- •Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
- •Any gender.
- •All the participants must agree to participate in the study and must sign the informed consent.
排除标准
- •Patients younger than
- •Patients with previous hypersensitivity to Benznidazole.
- •Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
- •Hepatic dysfunction
- •Renal dysfunction: serum creatinin higher than 3 mg/dl.
- •Pregnancy or lactation.
- •Low adhesion to treatment or check-up.
- •Impossibility of follow-up.
- •Severe adverse reaction to Benznidazole.
- •Any other situation that could be risky for the patient.
研究组 & 干预措施
Benznidazole
Other
干预措施: Benznidazole (Drug)
结局指标
主要结局
Population pharmacokinetic parameters of Benznidazole
时间窗: 2 months (treatment period)
Population pharmacokinetic model development
次要结局
- Adverse reactions(2 months (treatment period))
研究者
研究点 (1)
Loading locations...
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