Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Lead Sponsor:
Medicines Development for Global Health
Conditions:
Onchocerciasis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. ...
Eligibility Criteria
Inclusion
- Provision of written informed consent, or assent with parental or guardian written consent.
- Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
- Living in a village selected for the study.
- Age ≥ 12 years.
- 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.
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, oral diethylcarbamazine (DEC) or doxycycline (for \> 2 weeks) within 6 months of Baseline.
- Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
- Known or suspected allergy to ivermectin or moxidectin or their excipients.
- 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.
- Weight \> 88 kg.
- Infection with Loa loa.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT03876262
Start Date
May 3 2021
End Date
January 1 2026
Last Update
December 23 2025
Active Locations (1)
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1
Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri, Democratic Republic of the Congo