At a glance
ClinicalIndex Comparison Record- ✓S. mansoni positive diagnosis with stool egg counts >1 egg on at least one occasion, classified as light (1-99), moderate (100-399), or heavy (≥400) eggs per gram of faeces
- ✓Age 2-6 years for Part 1; age 3-24 months for Part 2
- ✓Minimum weight of 8.0 kg for children aged 2-6 years or 4.0 kg for infants aged 3-24 months
- ✓Parent/legal representative able to communicate with investigator, understand protocol requirements, and commit child to study visits (screening, 14-21 days post-treatment) and sample collection (stool, urine, blood)
- ✕Treatment with praziquantel, other antihelmintic, antimalarial, or antiretroviral compounds within 4 weeks prior to screening, or concurrent use of medications affecting praziquantel pharmacokinetics (carbamazepine, phenytoin, dexamethasone, chloroquine, rifampicin, cimetidine)
- ✕For breastfed children, maternal/wet nurse treatment with praziquantel within 3 days prior to investigational product administration
- ✕Prior history of adverse reactions to praziquantel treatment
- ✕Marked elevation of liver transaminases (ALT and/or AST) above 3x upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Raziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziquantel) in Schistosomiasis (S. Mansoni) Infected Children Aged 2-6 Years (Part 1), Followed by an Assessment of Efficacy and Safety With the Selected Formulation and Dosage in S. Mansoni Infected Infants Aged 3-24 Months (Part 2)
In Brief
A Phase 2 clinical trial evaluating Biltricide (racemate praziquantel) oral tablets, Racemate Praziquantel ODT, and 1 other intervention for Schistosomiasis. Completed, enrolled 444 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2.
Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.
Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9.