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Iverped: Dose-Ranging of Ivermectin and Albendazole for Trichuriasis in Preschool Children
NCT06184399Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2024
- Primary completion
- Aug 2024
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- CHILD-IVITAB
- Conditions
- trichuriasis
01
Overview
Phase 2, randomised, single-blind trial of CHILD-IVITAB in trichuriasis (6 arms). Primary endpoint: Cure Rate Against T. Trichiura. Started Jun 2024; status: completed.
02
Design
6 arms- Study design
- RandomizedSingle-blind
Placebo + Albendazole
Ivermectin ODT Placebo + Albendazole 400mg
Ivermectin 100µg/kg + Albendazole
Ivermectin ODT 100 µg/kg + Albendazole 400mg
Ivermectin 200µg/kg + Albendazole
Ivermectin ODT 200 µg/kg + Albendazole 400mg
Ivermectin 300µg/kg + Albendazole
Ivermectin ODT 300 µg/kg + Albendazole 400mg
Ivermectin 400µg/kg + Albendazole
Ivermectin ODT 400 µg/kg + Albendazole 400mg
Standard Ivermectin + Albendazole
Ivermectin Standard Tablets 200 µg/kg + Albendazole 400mg
03
Who it enrols
Preschool-aged children (2-5 years) with confirmed Trichuris trichiura infection, without major systemic illness or severe anaemia.
04
Endpoints
Primary
Cure Rate Against T. Trichiura
Secondary
Egg Reduction Rate Against T. Trichiura (Geometric Mean)
Egg Reduction Rate Against T. Trichiura (Arithmetic Mean)
Cure Rate Against A. Lumbricoides
Egg Reduction Rate Against A. Lumbricoides (Geometric Mean)
Egg Reduction Rate Against A. Lumbricoides (Arithmetic Mean)
Cure Rate Against Hookworm
Egg Reduction Rate Against Hookworm (Geometric Mean)
Egg Reduction Rate Against Hookworm (Arithmetic Mean)
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