L-PZQ ODT in Schistosoma Infected Children | NCT03845140 | Trialant
NCT03845140
Sponsor
Merck KGaA, Darmstadt, Germany
Status
Completed
Last Update Posted
Mar 21, 2024Actual
Enrollment
288Actual
Phase
Phase 3
Conditions
Schistosomiasis
Interventions
L-PZQ ODT 50 mg/kg
Biltricide®
L-PZQ ODT 60 mg/kg
Countries
Côte d’Ivoire
Kenya
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03845140
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MS200661_0003
Secondary IDs
Not provided
Brief Title
L-PZQ ODT in Schistosoma Infected Children
Official Title
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®)
Acronym
Not provided
Organization
Merck KGaA, Darmstadt, GermanyINDUSTRY
Status Module
Record Verification Date
Sep 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2, 2019Actual
Primary Completion Date
Oct 11, 2021Actual
Completion Date
Oct 11, 2021Actual
First Submitted Date
Feb 15, 2019
First Submission Date that Met QC Criteria
Feb 15, 2019
First Posted Date
Feb 19, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2022
Results First Submitted that Met QC Criteria
Sep 8, 2023
Results First Posted Date
Mar 21, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 8, 2023
Last Update Posted Date
Mar 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck KGaA, Darmstadt, GermanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Schistosomiasis
Keywords
Schistosomiasis
Children
L-praziquantel
Biltricide®
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
288Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
Drug: L-PZQ ODT 50 mg/kg
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.
Drug: Biltricide®
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.
Drug: L-PZQ ODT 50 mg/kg
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.
Drug: L-PZQ ODT 50 mg/kg
Cohort 4a: 3 months to 6 years L-PZQ ODT 50 mg/kg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
L-PZQ ODT 50 mg/kg
Drug
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
Cohort 1a: 4 to 6 years L-PZQ ODT 50 mg/kg
Cohort 2: 2 to 3 years L-PZQ ODT 50 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
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.
at Week 3
Secondary Outcomes
Measure
Description
Time Frame
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method
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.
at Week 3
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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 stool greater than or equal to ( >=) 1 egg per 1 occasion) according to World Health Organization (WHO) classification [1]: light (1 to 99 eggs per gram of feces), moderate (100 to 399 eggs per gram of feces) and heavy (>= 400 eggs per gram of feces) infections; S. haematobium positive (Cohort 4); diagnosis defined as positive egg counts in urine (>= 1 egg per 10 milliliter(mL) urine) according to WHO classification (Prevention and Control of Schistosomiasis and Soil Transmitted Helminthiasis. WHO Technical Report Series No. 912. WHO, Geneva, Switzerland, 2002).light (less than (<) 50 eggs per 10 mL of urine) and heavy (>=50 eggs per 10 mL of urine) infections
Participants have a minimum body weight of 8.0 Kilograms (Kg) in 2 to 6 years of age children and 5.0 Kg in 3 months to < 24 months of age infants and toddlers
Parent's or guardian/legally authorized representative's ability to communicate well with the Investigator and his/her delegate, to understand the protocol requirements and restrictions, and to be willing to have their children comply with the requirements of the entire study, that is:
To be examined by a study physician at screening and 17 to 21 days after treatment
To provide stool samples at screening and 17 to 21 days after treatment
To provide urine samples at screening and 17 to 21 days after treatment
To provide venous blood samples for laboratory assessments
To be housed in the clinic for 12 to 24 hours
To provide venous blood samples for pharmacokinetics (PK) assessments (for participants in the PK subset)
Participants have a minimum hemoglobin level of 10 gram per deciliter
Exclusion Criteria:
Participants with following medical conditions are excluded from the study; Findings in the clinical examination and/or laboratory safety examination on the treatment day, that in the opinion of the Investigator constitute a risk or a contraindication for the child's participation in the study or that could interfere with the study objectives, conduct or evaluation. This includes but is not restricted to bacterial or viral infections, such as dysentery, gastroenteritis, ascites, jaundice, etc.; Participants with seizures and/or medical history of seizures and/or other signs of potential central nervous system involvement; Participants with known cysticercosis, or with signs or symptoms (for example: subcutaneous nodules) suggestive of cysticercosis; Participants with an acute infection or other acute illness within the 7 days prior to study screening; Debilitating illness such as tuberculosis, malnutrition, etc.
Treatment with PZQ within the 4 weeks prior to the study screening
Concomitant treatment (within 2 weeks prior to enrollment) with medication that might affect the metabolism of PZQ, such as certain anti epileptics (for example: carbamazepine or phenytoin), glucocorticosteroids (for example: dexamethasone), chloroquine, rifampicin or cimetidine (see Biltricide® Summary of Product Characteristics [SmPC])
Treatment within the 2 weeks prior to the study screening with anti malarial medications
For infants and toddlers being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to PZQ ODT administration
Participation in any clinical study within 4 weeks prior to administration of PZQ ODT, or anticipated at any time until completion of the End of study visit
Participants with marked increases of the liver enzymes: alanine aminotransferase and/or aspartate aminotransferase above 3 times the upper limit of normal (ULN); total bilirubin level above 1.5 times the ULN
Participants with hepatosplenic schistosomiasis
Fever, defined as temperature above 37.5 degree Celsius axillary or oral mixed S. haematobium and S. mansoni infections
N'Goran EK, Odiere MR, Assande Aka R, Ouattara M, Aka NAD, Ogutu B, Rawago F, Bagchus WM, Bodding M, Kourany-Lefoll E, Tappert A, Yin X, Bezuidenhout D, Badenhorst H, Huber E, Dalken B, Haj-Ali Saflo O. Efficacy, safety, and palatability of arpraziquantel (L-praziquantel) orodispersible tablets in children aged 3 months to 6 years infected with Schistosoma in Cote d'Ivoire and Kenya: an open-label, partly randomised, phase 3 trial. Lancet Infect Dis. 2023 Jul;23(7):867-876. doi: 10.1016/S1473-3099(23)00048-8. Epub 2023 Mar 6.
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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.
FG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
FG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
FG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
FG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
FG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000100 subjects
FG00150 subjects
FG00230 subjects
FG00318 subjects
FG00430 subjects
FG00560 subjects
COMPLETED
FG000100 subjects
FG00149 subjects
FG00230 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Participant travelled outside study area
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis population (SAF) included all participants who received 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
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.
Modified intent to treat analysis population (mITT) included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Only 1 participant from Cohort 1b was lost to follow-up and was imputed as non-cured.
Posted
Count of Participants
Participants
at Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
Adverse Events Module
Frequency Threshold
5
Time Frame
up to Day 40
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Malaria
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA version 24.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.
Drug: L-PZQ ODT 50 mg/kg
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.
Drug: L-PZQ ODT 60 mg/kg
Cohort 3: 3 to 24 months L-PZQ ODT 50 mg/kg
Cohort 4a: 3 months to 6 years L-PZQ ODT 50 mg/kg
Biltricide®
Drug
Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.
Cohort 1b: 4 to 6 years Biltricide® 40 mg/kg
L-PZQ ODT 60 mg/kg
Drug
Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.
Cohort 4b: 3 months to 6 years L-PZQ ODT 60 mg/kg
Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.
Week 3 and Week 5
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100. Egg counts were determined by the Kato-Katz method.
Pre-treatment, Week 3 post-treatment
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100. Egg counts were determined by the urine filtration technique.
Pre-treatment, Weeks 3 and 5 post-treatment
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.
at Week 3
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
up to Day 40
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
up to Day 40
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Chemistry Parameter: C Reactive Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Chemistry Parameter: Total Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.
Baseline, Day 1
Change From Baseline in Urinalyses Parameter: Urobilinogen
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
Baseline, Day 1
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
Baseline, Week 3
Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.
Baseline, Week 3
Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.
Baseline, Week 3
Change From Baseline in Vital Signs: Temperature
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.
Baseline, Week 3
Number of Participants With Reaction to Study Intervention Administration
Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.
Day 1
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score
Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter [mm] visual analog scale [VAS]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".
Day 1
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Cmax was obtained directly from the plasma concentration versus time curve.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
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.
BG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
BG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
BG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
BG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
BG006
Total
Total of all reporting groups
100
BG00150
BG00230
BG00318
BG00430
BG00560
BG006288
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0005.4± 0.69
BG0015.5± 0.83
BG0023.0± 0.59
BG0031.4± 0.43
BG0044.6± 1.49
BG0055.1± 1.51
BG0064.8± 1.54
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00052
BG00121
BG00216
BG00311
BG0049
BG00528
BG006137
Male
BG00048
BG00129
BG00214
BG0037
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG000100
BG00150
BG00230
BG00318
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
Units
Counts
Participants
OG00098
OG00148
Title
Denominators
Categories
Title
Measurements
OG00086
OG00139
Secondary
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method
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.
mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.
Posted
Count of Participants
Participants
at Week 3
ID
Title
Description
OG000
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
Units
Counts
Participants
OG00029
OG00118
Title
Denominators
Categories
Title
Measurements
OG00027
OG00117
Secondary
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique
Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.
mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.
Posted
Count of Participants
Participants
Week 3 and Week 5
ID
Title
Description
OG000
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00029
OG00158
Title
Denominators
Categories
Week 3
ParticipantsOG00029
ParticipantsOG00158
Title
Measurements
OG00017
Secondary
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100. Egg counts were determined by the Kato-Katz method.
mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.
Posted
Number
95% Confidence Interval
percent reduction in egg count
Pre-treatment, Week 3 post-treatment
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
Units
Counts
Participants
OG00098
OG00148
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG00099.5(98.8 to 99.9)
OG00199.2(97.6 to 99.8)
OG00288.5(56.4 to 100.0)
OG003
Secondary
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100. Egg counts were determined by the urine filtration technique.
mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.
Posted
Number
95% Confidence Interval
percent reduction in egg count
Pre-treatment, Weeks 3 and 5 post-treatment
ID
Title
Description
OG000
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00029
OG00158
Title
Denominators
Categories
Week 3
ParticipantsOG00029
ParticipantsOG00158
Title
Measurements
OG00099.4(98.8 to 99.8)
Secondary
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.
mITT analysis population included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.
Posted
Count of Participants
Participants
at Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
Units
Counts
Participants
OG00098
OG00148
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG00063
OG00126
OG00218
OG003
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
SAF anlysis population included all participants who received 1 dose of study treatment.
Posted
Count of Participants
Participants
up to Day 40
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG00066
OG00131
OG00220
OG003
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
SAF anlysis population included all participants who received 1 dose of study treatment.
Posted
Count of Participants
Participants
up to Day 40
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Mild
Title
Measurements
OG00057
OG00127
OG00219
OG003
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
picogram
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.12± 1.273
OG0010.20± 0.665
OG0020.18± 0.348
OG003
Secondary
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
gram per liter (g/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Erythrocytes Mean Corpuscular HGB Concentration
Title
Measurements
OG000-0.6± 10.95
OG0013.1± 9.97
OG0025.2± 13.85
OG003
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
femtoliters
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.24± 2.657
OG001-0.04± 1.247
OG002-0.06± 0.905
OG003
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
10^12 cells per liter
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.003± 0.3245
OG001-0.061± 0.3792
OG002-0.240± 0.5650
OG003
Secondary
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.
Posted
Mean
Standard Deviation
percentage of cells
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Hematocrit
ParticipantsOG000100
ParticipantsOG00150
ParticipantsOG00230
ParticipantsOG003
Secondary
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
10^9 cells per liter
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Leukocytes
Title
Measurements
OG000-0.357± 2.2500
OG001-0.512± 2.3055
OG002-0.967± 1.9043
OG003
Secondary
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
units per liter (U/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Alanine Aminotransferase
Title
Measurements
OG000-1.91± 5.447
OG001-1.23± 6.245
OG002-2.03± 3.945
OG003
Secondary
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.
Posted
Mean
Standard Deviation
micromole per liter (mcmol/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Bilirubin
ParticipantsOG00056
ParticipantsOG00127
ParticipantsOG0026
ParticipantsOG003
Secondary
Change From Baseline in Chemistry Parameter: C Reactive Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
milligram per liter (mg/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.411± 9.6546
OG0010.004± 3.5448
OG002-0.336± 3.8792
OG003
Secondary
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.
Posted
Mean
Standard Deviation
millimole per liter (mmol/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Glucose
ParticipantsOG000100
ParticipantsOG00150
ParticipantsOG00230
ParticipantsOG003
Secondary
Change From Baseline in Chemistry Parameter: Total Protein
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
gram per liter (g/L)
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.20± 5.001
OG001-6.32± 5.018
OG002-6.22± 7.241
OG003
Secondary
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
ratio
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0066± 0.00797
OG0010.0064± 0.00722
OG0020.0060± 0.00781
OG003
Secondary
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
pH
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.33± 1.176
OG001-0.54± 1.068
OG002-0.50± 1.017
OG003
Secondary
Change From Baseline in Urinalyses Parameter: Urobilinogen
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
mcmol/L
Baseline, Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.01± 4.069
OG0010.19± 4.387
OG0020.48± 2.355
OG003
Secondary
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
millimeters of mercury (mmHg)
Baseline, Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Diastolic Blood Pressure
Title
Measurements
OG0002.7± 10.92
OG0012.0± 9.49
OG0022.9± 10.58
OG003
Secondary
Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
beats per minute
Baseline, Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.8± 14.65
OG001-2.6± 11.90
OG002-4.1± 20.46
OG003
Secondary
Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
breaths per minute
Baseline, Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.5± 4.09
OG001-0.1± 3.63
OG002-1.0± 2.98
OG003
Secondary
Change From Baseline in Vital Signs: Temperature
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.
SAF included all participants who received 1 dose of study treatment.
Posted
Mean
Standard Deviation
degree Celsius
Baseline, Week 3
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.02± 0.482
OG001-0.04± 0.529
OG0020.21± 0.734
OG003
Secondary
Number of Participants With Reaction to Study Intervention Administration
Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.
SAF anlysis population included all participants who received 1 dose of study treatment.
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG000100
OG00150
OG00230
OG003
Title
Denominators
Categories
Crying
Title
Measurements
OG0001
OG0014
OG0028
OG003
Secondary
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score
Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter [mm] visual analog scale [VAS]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".
SAF included all participants who received 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Median
Inter-Quartile Range
score on a scale
Day 1
ID
Title
Description
OG000
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00073
OG00134
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG00084.0(54.0 to 91.0)
OG00150.0(26.0 to 87.0)
OG00288.0(69.0 to 91.0)
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Cmax was obtained directly from the plasma concentration versus time curve.
The Pharmacokinetic Analysis Population (PKP) is a subset of the SAF population and consisted of all participants who received at least one dose of active Investigational Medicinal Product (IMP) and provide at least one measurable post-dose concentration.
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00017
OG00110
OG0029
OG003
Title
Denominators
Categories
R-PZO
Title
Measurements
OG000347± 281.4
OG00159.3± 60.39
OG0021470± 1326
OG003
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Tmax was obtained directly from the plasma concentration versus time curve.
PKP analysis population is a subset of the SAF population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration.
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00017
OG00110
OG0029
OG003
Title
Denominators
Categories
R-PZO
Title
Measurements
OG00002.00(0.500 to 8.00)
OG00101.00(0.00 to 12.0)
OG00203.00(01.00 to 12.0)
OG003
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
PKP analysis population is a subset of the SAF population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.
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.
OG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
OG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
OG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
OG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
OG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
Units
Counts
Participants
OG00017
OG00110
OG0029
OG003
Title
Denominators
Categories
R-PZO
ParticipantsOG00017
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG003
0
100
0
100
66
100
EG001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
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.
0
50
0
50
31
50
EG002
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg
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.
0
30
0
30
20
30
EG003
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg
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.
0
18
0
18
14
18
EG004
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg
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.
0
30
0
30
9
30
EG005
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg
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.
0
60
1
60
28
60
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0051 affected60 at risk
EG00023 affected100 at risk
EG00110 affected50 at risk
EG0029 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0052 affected60 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA version 24.0
Non-systematic Assessment
EG00018 affected100 at risk
EG0013 affected50 at risk
EG0024 affected30 at risk
EG0032 affected18 at risk
EG0040 affected30 at risk
EG0052 affected60 at risk
Vomiting
Gastrointestinal disorders
MedDRA version 24.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0015 affected50 at risk
EG0024 affected30 at risk
EG0031 affected18 at risk
EG0041 affected30 at risk
EG0050 affected60 at risk
Somnolence
Nervous system disorders
MedDRA version 24.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0013 affected50 at risk
EG0028 affected30 at risk
EG0032 affected18 at risk
EG0040 affected30 at risk
EG0051 affected60 at risk
Acarodermatitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Bronchitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0014 affected50 at risk
EG0021 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Conjunctivitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Diarrhoea infectious
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Escherichia infection
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Gastroenteritis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0011 affected50 at risk
EG0021 affected30 at risk
EG0033 affected18 at risk
EG0040 affected30 at risk
EG0053 affected60 at risk
Malaria
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0012 affected50 at risk
EG0022 affected30 at risk
EG0030 affected18 at risk
EG0041 affected30 at risk
EG0053 affected60 at risk
Nasopharyngitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0022 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0052 affected60 at risk
Rhinitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0030 affected18 at risk
EG0041 affected30 at risk
EG0050 affected60 at risk
Tinea capitis
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0013 affected50 at risk
EG0022 affected30 at risk
EG0031 affected18 at risk
EG0043 affected30 at risk
EG0051 affected60 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0011 affected50 at risk
EG0023 affected30 at risk
EG0031 affected18 at risk
EG0045 affected30 at risk
EG0053 affected60 at risk
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA version 24.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Lymphocytosis
Blood and lymphatic system disorders
MedDRA version 24.0
Non-systematic Assessment
EG0006 affected100 at risk
EG0011 affected50 at risk
EG0021 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0054 affected60 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0021 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0055 affected60 at risk
Thrombocytosis
Blood and lymphatic system disorders
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Feeling hot
General disorders
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Pyrexia
General disorders
MedDRA version 24.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0051 affected60 at risk
Transaminases increased
Investigations
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Ketonuria
Renal and urinary disorders
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0022 affected30 at risk
EG0030 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Leukocyturia
Renal and urinary disorders
MedDRA version 24.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0050 affected60 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected50 at risk
EG0020 affected30 at risk
EG0033 affected18 at risk
EG0041 affected30 at risk
EG0054 affected60 at risk
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected50 at risk
EG0020 affected30 at risk
EG0031 affected18 at risk
EG0040 affected30 at risk
EG0052 affected60 at risk
Urinary tract infection
Infections and infestations
MedDRA version 24.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0012 affected50 at risk
EG0020 affected30 at risk
EG0033 affected18 at risk
EG0040 affected30 at risk
EG0051 affected60 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D000079426
Vector Borne Diseases
21
BG00532
BG006151
0
BG0050
BG0060
0
BG0050
BG0060
30
BG00560
BG006288
0
BG0050
BG0060
0
BG0050
BG0060
0
BG0050
BG0060
OG001
50
Week 5
ParticipantsOG0000
ParticipantsOG00158
Title
Measurements
OG00155
18
95.6
(77.0 to 100.0)
OG00199.2(98.2 to 99.8)
Week 5
ParticipantsOG0000
ParticipantsOG00158
Title
Measurements
OG00199.3(97.6 to 100.0)
18
13
18
OG00430
OG00560
14
OG0049
OG00528
Participants with serious TEAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Participants with treatment-related TEAEs
Title
Measurements
OG00031
OG00114
OG00216
OG0034
OG0040
OG0055
18
OG00430
OG00560
14
OG0045
OG00521
Moderate
Title
Measurements
OG00021
OG0018
OG0029
OG0032
OG0044
OG00512
Severe
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
OG0051
18
OG00430
OG00560
0.34
± 0.699
OG0040.02± 0.325
OG0050.30± 1.046
18
OG00430
OG00560
3.9
± 11.25
OG0044.5± 6.52
OG0051.0± 11.82
Hemoglobin
Title
Measurements
OG000-0.8± 8.26
OG001-0.0± 11.56
OG002-4.4± 10.29
OG0031.1± 7.22
OG004-0.1± 6.89
OG0050.8± 7.43
18
OG00430
OG00560
0.16
± 2.101
OG004-0.88± 0.948
OG0050.61± 1.381
18
OG00430
OG00560
-0.044
± 0.3724
OG0040.001± 0.2921
OG005-0.028± 0.4000
18
OG00430
OG00560
18
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG0000.075± 3.3856
OG001-0.434± 3.0010
OG002-1.787± 3.9566
OG003-0.144± 2.6203
OG004-0.400± 2.3799
OG0050.103± 3.0415
Lymphocytes/Leukocytes
ParticipantsOG000100
ParticipantsOG00150
ParticipantsOG00230
ParticipantsOG00318
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG0004.35± 10.617
OG0011.69± 9.171
OG0020.44± 10.390
OG003
Mixed Cells/Leukocytes
ParticipantsOG000100
ParticipantsOG00150
ParticipantsOG00230
ParticipantsOG00318
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG000-1.35± 6.526
OG0010.45± 7.579
OG0020.07± 4.816
OG003
Neutrophils/Leukocytes
ParticipantsOG00090
ParticipantsOG00146
ParticipantsOG00226
ParticipantsOG00318
ParticipantsOG0046
ParticipantsOG00560
Title
Measurements
OG000-2.01± 13.738
OG001-3.03± 13.733
OG0020.15± 13.430
OG003
18
OG00430
OG00560
0.317
± 2.1385
OG004-0.390± 1.9805
OG0050.340± 1.9324
Platelets
Title
Measurements
OG000-21.2± 56.04
OG001-24.5± 39.08
OG002-28.6± 61.75
OG00349.7± 170.67
OG004-10.0± 33.12
OG005-14.0± 62.78
18
OG00430
OG00560
-0.40
± 5.959
OG004-1.27± 2.532
OG005-1.57± 3.614
Aspartate Aminotransferase
Title
Measurements
OG000-2.50± 9.271
OG001-0.59± 12.759
OG002-2.55± 8.910
OG0034.41± 27.941
OG004-2.87± 4.805
OG005-1.93± 4.430
18
OG00430
OG00560
6
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000-1.48± 3.056
OG001-0.22± 2.531
OG0020.25± 3.651
OG003-1.62± 3.075
Creatinine
ParticipantsOG000100
ParticipantsOG00150
ParticipantsOG00230
ParticipantsOG00318
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG0004.565± 10.7273
OG0016.386± 13.9391
OG0023.340± 16.7903
OG003
Direct Bilirubin
ParticipantsOG00044
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00312
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG0000.09± 0.937
OG0010.06± 0.278
OG0020.05± 0.219
OG003
18
OG00430
OG00560
0.872
± 4.6025
OG004-0.588± 4.2572
OG0050.283± 3.3653
18
OG00430
OG00560
18
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG000-0.056± 1.2426
OG0010.277± 1.3265
OG0020.207± 1.2011
OG003-0.354± 1.4042
OG004-0.070± 1.0867
OG005-0.052± 1.4386
Urea
ParticipantsOG00056
ParticipantsOG00127
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.061± 0.1159
OG0010.087± 0.0691
OG0020.082± 0.0611
OG003
Urea Nitrogen
ParticipantsOG00044
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00312
ParticipantsOG00430
ParticipantsOG00560
Title
Measurements
OG0001.443± 1.2279
OG0011.257± 1.1638
OG0022.017± 1.7597
OG003
18
OG00430
OG00560
0.16
± 4.918
OG004-3.40± 5.308
OG005-3.18± 4.959
18
OG00430
OG00560
0.0039
± 0.00932
OG0040.0047± 0.00787
OG0050.0091± 0.00704
18
OG00430
OG00560
-0.11
± 0.654
OG004-0.42± 0.872
OG005-0.43± 0.899
18
OG00430
OG00560
0.00
± 0.000
OG004-0.03± 0.146
OG0050.01± 0.090
18
OG00430
OG00560
-1.3
± 10.27
OG0041.2± 12.49
OG0054.1± 11.73
Systolic Blood Pressure
Title
Measurements
OG000-0.5± 12.37
OG001-1.4± 12.17
OG0020.3± 12.58
OG0030.8± 8.06
OG004-1.8± 9.78
OG0053.7± 12.07
18
OG00430
OG00560
-9.6
± 20.74
OG004-3.7± 18.78
OG005-1.7± 11.90
18
OG00430
OG00560
-3.4
± 8.91
OG004-2.6± 3.85
OG005-0.9± 4.02
18
OG00430
OG00560
-0.10
± 0.484
OG004-0.01± 0.529
OG0050.08± 0.427
18
OG00430
OG00560
8
OG0042
OG0052
Spitting
Title
Measurements
OG0001
OG0013
OG0026
OG0036
OG0040
OG0053
Diarrhoea
Title
Measurements
OG00016
OG0013
OG0024
OG0032
OG0040
OG0052
Sleepiness
Title
Measurements
OG0007
OG0013
OG0027
OG0032
OG0040
OG0051
Abdominal pain
Title
Measurements
OG00021
OG0019
OG0029
OG0030
OG0040
OG0052
Fever
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
Vomiting
Title
Measurements
OG0007
OG0014
OG0024
OG0031
OG0040
OG0050
Other
Title
Measurements
OG0003
OG0011
OG0020
OG0030
OG0040
OG0051
35
88.0
(79.0 to 92.0)
2
OG00414
OG00515
NA
± NA
Mean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.
OG004523± 667.7
OG005300± 239.7
S-PZO
Title
Measurements
OG0001.27± 2.834
OG001343± 298.9
OG0020.00± 0.000
OG003NA± NAMean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.
OG0040.00± 0.000
OG0050.360± 1.394
2
OG00414
OG00515
NA
(NA to NA)
Median and Full range was not calculated for participants fewer than 3 as per planned analysis.
OG0041.50(0.500 to 6.02)
OG00503.00(0.500 to 8.02)
S-PZO
Title
Measurements
OG0000.00(0.00 to 4.00)
OG0012.49(0.500 to 12.0)
OG0020.00(0.00 to 8.00)
OG003NA(NA to NA)Median and Full range was not calculated for participants fewer than 3 as per planned analysis.
OG0040.00(0.00 to 5.00)
OG0050.00(0.00 to 5.00)
2
OG00414
OG00515
2
ParticipantsOG00414
ParticipantsOG00515
Title
Measurements
OG0001080± 1036
OG001184± 150.0
OG0022720± 1718
OG003NA± NAMean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.