Phase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Proportion of patients with sustained negativation of parasitemia according to the results of qualitative PCR tests
研究概览
简要总结
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.
详细描述
Chagas disease is a vector-borne parasitic infection affecting an estimated 6 million people worldwide. Very few people have been able to access antiparasitic treatment for the disease, and about 20% of those who do initiate treatment are unable to complete it due to the long duration (2 months) and side effects associated with the current regimen. Benznidazole is one of only two drugs with proven efficacy against Trypanosoma cruzi, the parasite that causes the disease. An earlier Phase 2 clinical trial, BENDITA, indicated 89% of 30 patients treated with a shorter (2-week) regimen of benznidazole maintained sustained parasite clearance after 12 months of follow-up, with no discontinuations of treatment due to side effects. The current study will evaluate shorter treatment regimens with benznidazole in a Phase III clinical trial. NuestroBen will assess the efficacy and safety of 2-week and 4-week regimens of BZN (300 mg daily), compared to the standard treatment of BZN 300 mg daily for 8 weeks, in terms of reducing and eliminating the T. cruzi parasite in adults in the chronic phase of Chagas disease with the indeterminate form or mild cardiac progression. Efficacy will be measured through conversion from positive to negative parasitaemia according to the results of qualitative PCR tests from the end of treatment, and up to 12 months of follow-up from the end of treatment. Safety will be compared according to the frequency and severity of adverse events. Patients adherence to treatment in each study arm will also be described.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Short regimen of benznidazole 2 weeks
Experimental: Short regimen of benznidazole Participants will receive an investigational treatment of benznidazole for 2 weeks.
Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.
干预措施: Short regimen of benznidazole (Drug)
Short regimen of benznidazole 4 weeks
Experimental: Short regimen of benznidazole Participants will receive an investigational treatment of benznidazole for 4 weeks.
Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 4 weeks.
干预措施: Short treatment with benznidazole (Drug)
Standard treatment with benznidazole
Active Comparator: Standard treatment with benznidazole Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks
干预措施: Standard treatment with benznidazole (Drug)
结局指标
主要结局
Proportion of patients with sustained negativation of parasitemia according to the results of qualitative PCR tests
时间窗: From the end of treatment, and up to 12 months of follow-up from the end of treatment.
Sustained parasitological response will be determined by negative serial qualitative PCR results (two negative PCR results from three DNA extractions from a sample) from the end of treatment with the elimination of sustained parasitaemia until the end of 12 months' follow-up from the end of treatment.
次要结局
- Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption(From the end of treatment, and up to 12 months of follow-up from the end of treatment.)
- Proportion of patients with negative parasitemia at 1, 4, 6 and 8 months follow-up form the end of treatment(1, 4, 6 and 8 months from the end of treatment)
- Descriptions of patients adherence to treatment in each study arm.(2, 4 and 8 weeks)
- Incidence and severity of adverse events(From the end of treatment, and up to 12 months of follow-up from the end of treatment)