PACTR201907565746388已完成1 期
An open-label study of the pharmacokinetics and safety of a single dose of moxidectin per oral in subjects aged 4 to 17 years with (or at risk of) onchocerciasis to identify an optimal dose for treatment of children 4 to 11 years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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): < 30 kg
- •Cohort II (8 to 11 years): < 18 kg
- •Cohort III (4 to 7 years): < 12 kg
- •10. Clinically relevant laboratory abnormalities at Screening, including:
- •Hemoglobin < 9.5 grams per deciliter (g/dL)
- •Neutrophil (granulocyte) count < 1.5 x 109/L
- •Platelet count < 110 x 109/L
- •Alanine aminotransferase (ALT) > 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
研究者
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