Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerc… (NCT04311671) | Clinical Trial Compass
CompletedPhase 3
Safety of a Single Dose 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 Albendazole
Côte d’Ivoire, Democratic Republic of the Congo12,979 participantsStarted 2021-05-03
Plain-language summary
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of 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 albendazole.
Who can participate
Age range4 Years
SexALL
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Inclusion criteria
✓. Provision of written informed consent, or assent with parental or guardian written consent\*
✓. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
✓. Living in an onchocerciasis endemic area.
✓. Age ≥4 years
✓. 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). \* Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to \<6 years
Exclusion criteria
✕. Pregnant or breast-feeding.
✕. 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.
✕. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
✕. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
✕. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
✕. 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.
What they're measuring
1
Incidence and Severity of Treatment Emergent Adverse Events