临床试验/NCT01162967

NCT01162967

已完成

2 期

PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE

Hospital Universitari Vall d'Hebron Research Institute3 个研究点分布在 1 个国家目标入组 78 人2010年9月

适应症Chagas Disease

干预措施Benznidazole Posaconazole

概览

阶段: 2 期
干预措施: Benznidazole
疾病 / 适应症: Chagas Disease
发起方: Hospital Universitari Vall d'Hebron Research Institute
入组人数: 78
试验地点: 3
主要终点: Parasitological cure measured by a real time PCR in blood sample
状态: 已完成
最后更新: 12年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.

注册库

clinicaltrials.gov

开始日期

2010年9月

结束日期

2013年3月

最后更新

12年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Hospital Universitari Vall d'Hebron Research Institute

责任方

Sponsor

入排标准

入选标准

•Consenting patients with serological evidence of Chagas infection and positive PCR real time

排除标准

未提供

研究组 & 干预措施

Benznidazole

干预措施: Benznidazole

Posaconazole, low dose

干预措施: Posaconazole

Posaconazole, high dose

干预措施: Posaconazole

结局指标

主要结局

Parasitological cure measured by a real time PCR in blood sample

时间窗: 12 months after starting treatment

PCR negative at the end of follow up

次要结局

Parasitological cure measured by real time PCR in blood sample(End of treatment, weeks 8, 16, 24 and 40 after treatment)
Safety and tolerability of both drugs(First 2 months)

研究点 (3)

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