Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Recruiting
Phase 3
Interventional Study
Soil-Transmitted Helminths
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 5 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20,000 (estimated)
- Sponsor
- Insud Pharma · Industry
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About This Trial
An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the tre…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:
1. Age: 5 to 17 years old (included).
2. Height: over 110 cm.
3. Parental acceptance to participate in the study by obtaining written informed cons…
Contacts