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

PHASE2CompletedINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

June 12, 2016

Primary Completion Date

October 30, 2018

Study Completion Date

November 17, 2018

Conditions
Schistosomiasis
Interventions
DRUG

Biltricide (racemate praziquantel) oral tablets

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.

DRUG

Racemate Praziquantel ODT

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.

DRUG

Levo Praziquantel ODT

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.

Trial Locations (1)

Unknown

Please Contact the Communication Center, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT02806232 - An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni) | Biotech Hunter | Biotech Hunter