NCT04024163进行中（未招募）3 期
Prospective, Single-arm, Multicentre Study, Using a Historical Control, to Evaluate the Efficacy/Safety and Population Pharmacokinetics of Benznidazole in Children With Chronic Indeterminate Chagas Disease
Insud Pharma11 个研究点 分布在 3 个国家目标入组 178 人开始时间: 2019年9月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 11
- 主要终点
- Serological Cure by Conventional ELISA
研究概览
简要总结
This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 18 years (age limits inclusive)
- •Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
- •Written informed consent by parent/legal representative and informed assent from patients if >7 years old when applicable (as requirements may vary by country and by site)
- •Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment
排除标准
- •Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
- •Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
- •Signs and/or symptoms of acute Chagas Disease
- •Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
- •History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
- •Immunocompromised (clinical history compatible with human immunodeficiency virus (HIV) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive drugs)
- •Abnormal laboratory test values (as per protocol-specified ranges) at Screening for the following parameters: total white blood cell (WBC) count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine
- •Abnormal ECG (as per protocol-specified ranges) and/or any Chagas disease associated findings
- •Any condition that prevents the patient from taking oral medication
- •Patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (IMP)
- •Evidence or history of alcohol or drug abuse (within the last 12 months)
- •Any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment
- •Employee of the Investigator or trial centre, or family member of the employees or the Investigator
- •Any condition that, in the opinion of the Investigator, may jeopardise the trial conduct according to the protocol
研究组 & 干预措施
Benznidazole
Experimental
Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days
干预措施: Benznidazole (Drug)
结局指标
主要结局
Serological Cure by Conventional ELISA
时间窗: 72-month follow up
Percentage of patients with negative conventional ELISA results as a measure of serological cure at the end of the 72-month follow up
次要结局
- Serological Cure by Conventional ELISA at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Serological Cure by two conventional serology tests at 72 month(72 months of follow-up)
- Serological Cure by two conventional serology tests at 48 months(48 months of follow-up)
- Serological Cure by three serology tests at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Serological Cure by Non-Conventional ELISA at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Cure by qPCR at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Progression of clinical disease at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Serological titres reduction at different timepoints(Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up)
- Progression of clinical disease and serological cure by one assay at different timepoints(48 and 72 months of follow-up)
- Progression of clinical disease and serological cure by two assays at different timepoints(48 and 72 months of follow-up)
研究者
研究点 (11)
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