drugset / Trial / NCT02806232
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
RandomizedParallel-groupOpen-labelTreatment
Summary
The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2 investigated efficacy and safety with the selected formulation and dosage in S. mansoni infected children aged between 3 months - 2 years.
Timeline
- Start
- 2016-06-12
- Primary completion
- 2018-10-30
- Completion
- 2018-11-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levo Praziquantel | Unknown | 30 mg/kg | Oral |
| Subject | Levo Praziquantel | Unknown | 45 mg/kg | Oral |
| Subject | Levo Praziquantel | Unknown | 50 mg/kg | Oral |
| Subject | Levo Praziquantel | Unknown | 60 mg/kg | Oral |
| Subject | Praziquantel | Small molecule | 20 mg/kg | Oral |
| Subject | Praziquantel | Small molecule | 40 mg/kg | Oral |
| Subject | Praziquantel | Small molecule | 60 mg/kg | Oral |