PACTR202004639229710招募中3 期
A randomized, double blind, parallel trial in the Democratic Republic of Congo (DRC) comparing the safety and efficacy of annual or biannual doses of moxidectin or ivermectin for treatment of onchocerciasis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
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
- •1.Provision of written informed consent, or assent with parental or guardian written consent.
- •2.Mean = 10 O. volvulus mf/mg skin, determined by four skin snips.
- •3.Living in a village selected for the study.
- •4.Age = 12 years.
- •5.All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.
排除标准
- •1.Pregnant or breast-feeding.
- •2.Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
- •3.Has received ivermectin, oral diethylcarbamazine (DEC) or doxycycline (for > 2 weeks) within 6 months of Baseline.
- •4.Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
- •5.Known or suspected allergy to ivermectin or moxidectin or their excipients.
- •6.Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
- •7.Weight > 88 kilograms.
- •8.Infection with Loa loa.
研究者
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