A randomized, double blind, parallel group clinical trial to evaluate the safety of moxidectin compared with ivermectin in individuals living in onchocerciasis endemic areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole

Medicines Development for Global Health0 个研究点目标入组 12,500 人开始时间: 2020年3月13日最近更新: 2023年5月29日

适应症

试验速览

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•1.Provision of written informed consent, or assent with parental or guardian written consent.
•2.Known O. volvulus skin microfilariae density =0 microfilariae/mg skin
•3.Living in an onchocerciasis endemic area.
•4.Age = 12 years.
•5.All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3).

•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 or oral diethylcarbamazine (DEC) within 30 days of Baseline.
•4.Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
•5.Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high LF co-endemicity requiring concomitant albendazole administration,known or
•suspected allergy to albendazole and its excipients
•6.Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
•7.Infection with Loa loa

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