Clinical Trial: An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Praziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziq

Brief Summary: The Phase II study consisting 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 2a investigates efficacy and safety in children 3 months to 2 years in an age-de-escalating design and part 2b is optional and investigates the efficacy of L-PZQ in S. hematobium.