NCT03845140

L-PZQ ODT in Schistosoma Infected Children

An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 3 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.

Conditions

• Schistosomiasis

Interventions

Type	Name	Description
DRUG	L-PZQ ODT 50 mg/kg	Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
DRUG	Biltricide®	Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.
DRUG	L-PZQ ODT 60 mg/kg	Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.

Timeline

• Start date: 2019-09-02
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2019-02-19
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

2 sites across 2 countries: Côte d’Ivoire, Kenya