Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03845140 | L-PZQ ODT in Schistosoma Infected Children | PHASE3 | COMPLETED | 288 | — | — | Sep 2, 2019 | Oct 11, 2021 | Mar 21, 2024 | 2 | Côte d’Ivoire, Kenya |
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1a: 4 to 6 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1. |
| Cohort 1b: 4 to 6 years Biltricide® 40 mg/kg | ACTIVE_COMPARATOR | Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 2: 2 to 3 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 3: 3 to 24 months L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 4a: 3 months to 6 years L-PZQ ODT 50 mg/kg | EXPERIMENTAL | Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1. |
| Cohort 4b: 3 months to 6 years L-PZQ ODT 60 mg/kg | EXPERIMENTAL | Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1. |
| Name | Type | Description |
|---|---|---|
| L-PZQ ODT 50 mg/kg | DRUG | Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1. |
| Biltricide® | DRUG | Participants received single oral dose of Biltricide® 40 mg/kg on Day 1. |
| L-PZQ ODT 60 mg/kg | DRUG | Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1. |
Inclusion Criteria: * Age of the participant is 4 to 6 years of age (Cohorts 1 and 4), 2 to 3 years of age (Cohorts 2 and 4) 3 to less than 24 months of age (Cohorts 3 and 4) * Participants are; Schistosoma (S.) mansoni positive (Cohorts 1, 2, and 3); diagnosis defined as positive egg counts in sto...