Status:
COMPLETED
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
Lead Sponsor:
Medicines Development for Global Health
Conditions:
Onchocerciasis
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief 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 indi...
Eligibility Criteria
Inclusion
- 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
- 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.
- Infection with Loa loa.
- Height \<90 cm.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2024
Estimated Enrollment :
12997 Patients enrolled
Trial Details
Trial ID
NCT04311671
Start Date
May 3 2021
End Date
September 27 2024
Last Update
October 9 2024
Active Locations (2)
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1
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Abidjan, Côte d’Ivoire
2
Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri, Democratic Republic of the Congo