PACTR202011638938739Other2 期
Efficacy and safety of fexinidazole in patients with Human African Trypanosomiasis (HAT) due to Trypanosoma brucei rhodesiense: a multicentre, open-label clinical trial
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 50
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
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •Signed Informed Consent Form (plus assent for children)
- •= 6 years old
- •= 20 kg body weight
- •Ability to ingest at least one complete meal per day (or at least one Plumpy’Nut® sachet)
- •Karnofsky index = 40
- •Parasitological confirmed of T.b. rhodesiense infection
- •Having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule
- •Agreement to be hospitalised for a minimum of 13 days and to receive the study treatment
排除标准
- •Active clinically relevant medical conditions other than HAT that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study (e.g. Patients at risk of QT interval prolongations, cf. details listed in IB section Possible Risk),
- •Compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness
- •Known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole) or to any of the excipients
- •Patients previously enrolled in the study or having already received fexinidazole
- •Patients with severe hepatic impairment (ex: clinical signs of cirrhosis or jaundice)
研究者
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