Onchocerciasis Paediatrics
Conditions
Interventions
Sponsors
Medicines Development for Global Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 17 years, inclusive: Cohort I: 12 to 17 years; Cohort II: 8 to 11 years; Cohort III: 4 to 7 years; 2. Live in a region designated by the World Health Organization (WHO) as endemic for O. volvulus infection (World Health Organization, 2017). Specifically, participants will be recruited from the Kpassa sub-district of the Nkwanta North district.The specific communities will include Wii, Jagri-Do, and Azua where mass drug administration with ivermectin for onchocerciasis commenced in October 2017; 3. Willing and able to remain at the study clinic from Screening up to Day 7; 4. Provision of parental or guardian written informed consent and assent as appropriate; 5. Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Screening until 6 months after treatment with study drug.
Exclusion criteria
Exclusion criteria: 1. History of serious medical or psychiatric condition which, in the opinion of the investigator, would put the subject at increased risk by participating in the study or jeopardize study outcomes; 2. Known or suspected concurrent clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunological disorders or malignancy, congenital heart disease, chronic lung disease 3. Has received an investigational product within 28 days or 5 half-lives of Screening, whichever is longer; 4. Has received ivermectin or any other anti-helminthic treatments within 28 days of Screening; 5. Has received a vaccination within 7 days of Screening; 6. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin; 7. Poor venous access; 8. Unable to swallow tablets; 9. Weight: Cohort I (12 to 17 years): 1.5 times the upper limit of normal range (ULN) Total bilirubin > 1.5 times ULN 11. Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) positive 12. Known or suspected malaria or other ongoing viral, bacterial, or plasmodium infection at Screening and/or Baseline; 13. Loa loa co-infection; 14. Unwilling, unlikely or unable to comply with all protocol specified assessments. 15. For females of child bearing potential, pregnant or breastfeeding, or planning to become pregnant 16. Previous enrolment in this study 17. Is a sibling of another child already enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve of moxidectin - Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration versus time curve (zero to infinity) of moxidectin - Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method. ;Maximum observed plasma concentrations (Cmax) of moxidectin - Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.;Incidence and severity of adverse events, assessed by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, Version 2.1. | — |
Countries
Ghana
Contacts
Public ContactSally Kinrade
Moxidectin for Onchocerciasis Project Leader
Outcome results
None listed