ISRCTN85534673已完成3 期
International randomized controlled phase III trial of DB289 versus pentamidine for the treatment of first stage Human African Trypanosomiasis (HAT)
Immtech Pharmaceuticals, Inc. (USA)0 个研究点目标入组 250 人开始时间: 2005年8月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The patient has first stage T. b. gambiense infection, i.e. parasitologically confirmed infection in the blood or lymph node aspirate and White Blood Cell count (WBC) less than or equal to 5 mm^3 detected in the CerebroSpinal Fluid (CSF) by microscopic examination.
- •2. Patient is male or female 12 years of age or older and more than or equal to 30 kg.
排除标准
- •1. The patient has possible or confirmed second stage T. b. gambiense infection, i.e. presence of parasite in the CSF upon microscopic examination or a WBC count in the CSF of more than 5 mm^-3
- •2. Active clinically relevant medical conditions that in the Investigator's opinion may jeopardise subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known Human Immunodeficiency Virus (HIV) infection, Central Nervous System (CNS) trauma or seizure disorders
- •3. Coma Score of less than nine on the Glasgow Coma Scale
研究者
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